Sleep DisturbanceNCT04956341
Auricular Acupuncture for Sleep Disturbances
A study testing Auricular acupuncture and Standard treatment in people with Sleep Disturbance, run by Paul Crawford at 1 site in United States.
Trial summary
A randomized controlled trial of auricular acupuncture for sleep disturbances. Objective 1: Evaluate the effectiveness of a specific protocol of auricular acupuncture in the treatment of sleep disturbance among active duty and otherDoD beneficiaries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Auricular acupuncture and Standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Active Duty members and DoD beneficiaries ages 18-80 with complaints of sleep disturbances.
- PROMIS-16 Sleep-Related Impairment Scale with a score of medium or severe (T-Score greater than or equal to 60).
Who cannot join
- Patients with OSA who are prescribed CPAP/BiPAP and either do not use it or use it <70% of time per patient report.
- Investigators seek to exclude individuals with sleep-related medical or psychiatric conditions that are so severe as to render these patients inappropriate for treatment in primary care or simple mental health without psychiatry oversight or that acupuncture cannot be expected to have an effect on (e.g., thyroid disease). Specifically, exclusion criteria will include:
- Psychosis
- Thyroid disease undergoing active adjustment of medication.Depression, with suicidality. (clinician judgment)
- Greater than 10 mg equivalent of diazepam equivalent per day for any reason
- Non-response to greater than 2 PSTD treatments
- Having acupuncture not related to sleep in the past 3 months
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial
A randomized controlled trial of auricular acupuncture for sleep disturbances.
- Objective 1: Evaluate the effectiveness of a specific protocol of auricular acupuncture in the treatment of sleep disturbance among active duty and otherDoD beneficiaries.
- Objective 2: Test whether a brief course of auricular acupuncture treatments among active duty and other DoD beneficiaries with sleep disturbance willalso decrease severity of anxiety, depression, pain and improve sleep and social functioning in subgroup analysis of subjects with known or newlydiagnosed mental health disorders (e.g., anxiety disorders, depression).
- Null Hypothesis: Auricular Acupuncture has no effect on sleep disturbance.
- Alternative Hypothesis: Auricular Acupuncture reduces sleep disturbance.
Read the detailed description
Active duty members and DoD beneficiaries aged 18-80 years old and meeting the inclusion/exclusion criteria will be offered an opportunity to participate.They will be recruited from the clinics at 99MDG (Nellis AFB), 96MDG (Eglin AFB), and 375 MDG (Scott AFB). All of the below items are research-relatedunless marked as 'standard of care'. All visits will last approximately 30 minutes in length.
Screening Visit:
- Obtain and document signed Informed Consent document and HIPAA Authorization.
- Review past medical history to verify the inclusion/exclusion criteria
- We will record health care resource utilization to include Number of hospital or clinic visits (previous encounters) for sleep problems in the past 12 months
- Medication use (Sleep medications, stimulant medications, energy drinks at least once/week), co-morbidities, phone number, e-mail address, dateof birth, gender, race, ethnicity, highest education level, total number of children in household), Service characteristics (officer, enlisted, retired)(service branch), History of deployment (never deployed, previously deployed, number of deployments), Usual Work pattern (Day, night),
- Record whether the subject has a history of Obstructive Sleep Apnea (OSA) and whether it is treated or untreated. If treated, do they use aContinuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) machine? If patient uses CPAP/BiPAP, do they use it atleast 70% of the time as reported by patient or CPAP/BiPAP recent data pull in medical record. These questions are asked due to a possiblerelationship between OSA and sleep disturbance (3); those who have OSA and do not use a CPAP or use one infrequently need to be accounted forso as to not to confound data analysis.
- PROMIS-16 Sleep-Related Impairment Scale
Randomization:
Subjects who score a medium or severe on the PROMIS-16 (T-Score greater than or equal to 60). Sleep-Related Impairment Scale will berandomized into one of two groups and the intervention will be performed. The investigators acknowledge that any of these standard treatmentsmay be shorter or longer in duration than the duration of the study. There is no additional risk to subjects for continuing to track their sleeppatterns and mental health scores on various instruments shorter or longer than standard of care treatments. Furthermore, this study is meant tobe a pragmatic trial-there are many evidence based and not evidence based treatments for sleep disturbance that are considered standard ofcare. We seek to allow any of these treatments to proceed and evaluate the addition of auricular acupuncture as it can be applied in a clinic setting:
- Group 1: Standard treatment from Primary Care Manager (PCM) or Mental Health or both
- Group 2: Standard treatment from PCM or Mental Health or both + auricular Acupuncture
Visit 1 (0 weeks may be same day as screening visit):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
- All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 yearsor older complete the questionnaire on Survey Monkey at Visit 1, Visit 8, and Visit 10 (the dates will be on the back of the CSI-4 business card).They will be asked to have the same person complete all 3 questionnaires during the study.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16 Sleep-Related Impairment Scale (PROMIS-16)
- Measure Yourself Medical Outcome Profile (MYMOP) Initial
Visit 2 (1 week):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
Visit 3 (2 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
Visit 4 (3 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles -placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
Visit 5 (5 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 6 (7 Weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 7 (9 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 8 (11 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
- Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
Visit 9 (15 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
Visit 10 (23-24 Weeks):
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
- Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
CROSSOVER:
At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into theacupuncture treatment arm of the study as outlined above. This will not be part of the analysis. If a patient in the acupuncture group is still havingsymptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
All study subjects will receive a $100 gift card at the completion of the 24 weeks. Active Duty and GS employees (who are also DoD beneficiaries) mayalso receive a $100 gift card only upon completion of the appropriate off-duty employment paperwork with their supervisor
- Conditions
- Sleep Disturbance
- Being tested
- Auricular acupuncture, Standard treatment
- Keywords
- acupuncture, auricular acupuncture, sleep
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureDevice
Auricular acupuncture treatments will be utilizing ASP needles. The needles will stay in and fall out on their own (usually 3-10 days). For some patients who are acupuncture naïve, Seirin 15mm needles will be placed and allowed to remain for 45 minutes. This option will be provided to all subjects for their first treatment. Auricular acupuncture treatment possible locations will be as defined as: Master Cerebral/Prefrontal cortex, Amygdala, Hippocampus, Hypothalamus, Point Zero, Shen Men, Insomnia 1,Insomnia 2 OR Prefrontal Cortex, Reticular formation, Pineal gland, Hypothalamus, Point zero. In acupuncture parlance, the patient will be treated with ATP plus sleep I on first visit, then the acupuncturist will continue to use that treatment for each subsequent visit with the potential to add ATP plus sleep II. Both ears will be treated unless the patient requests that one be left open. The acupuncturist may use sleep I in one ear and sleep II in the other.
Standard treatmentOther
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment from PCM or Mental Health or both + auricular acupuncture | Experimental | Not described Receives: Device: Auricular acupuncture |
| Standard treatment from Primary Care Manager (PCM) or Mental Health or both | Placebo comparator | Not described Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: baseline, pre-intervention
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 1 (0 weeks/same day as screening)
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 2 (1 week) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 3 (2 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 4 (3 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 5 (5 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 6 (7 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 7 (9 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 8 (11 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 9 (15 weeks) post study visit procedures appropriate to subject randomization group
PROMIS Sleep-Related Impairment Scale
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first.
Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measured: visit 10 (23-24 weeks) post study visit procedures appropriate to subject randomization group
Measure Yourself Medical Outcome Profile (MYMOP) Initial
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measured: visit 1 (0 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measured: visit 4 (3 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measured: visit 8 (11 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measured: visit 9 (15 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measured: visit 10 (23-24 weeks)
Secondary outcomes (3)
Couples Satisfaction Index CSI)
The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction.
All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 years or older complete the questionnaire on Survey Monkey.
Measured: visit 1 (0 weeks)
Couples Satisfaction Index CSI)
The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction.
All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 years or older complete the questionnaire on Survey Monkey.
Measured: visit 8 (11 weeks)
Couples Satisfaction Index CSI)
The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction.
All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 years or older complete the questionnaire on Survey Monkey.
Measured: visit 10 (23-24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 May 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into the acupuncture treatment arm of the study as outlined above. This will not be part of the analysis. If a patient in the acupuncture group is still having symptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Crawford
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Paul Crawford, Mike O'Callaghan Military Hospital
- Investigators
- Paul Crawford, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956341
- Sponsor's protocol ID
- FWH20210106H
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan on sharing data.
Publications
Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237.
PubMed 25397825Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
PubMed 15229303A Caldwell J, Knapik JJ, Lieberman HR. Trends and factors associated with insomnia and sleep apnea in all United States military service members from 2005 to 2014. J Sleep Res. 2017 Oct;26(5):665-670. doi: 10.1111/jsr.12543. Epub 2017 Apr 27.
PubMed 28448689Colvonen PJ, Straus LD, Stepnowsky C, McCarthy MJ, Goldstein LA, Norman SB. Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. Curr Psychiatry Rep. 2018 Jun 21;20(7):48. doi: 10.1007/s11920-018-0916-9.
PubMed 29931537Troxel WM, Shih RA, Pedersen ER, Geyer L, Fisher MP, Griffin BA, Haas AC, Kurz J, Steinberg PS. Sleep in the Military: Promoting Healthy Sleep Among U.S. Servicemembers. Rand Health Q. 2015 Nov 30;5(2):19. eCollection 2015 Nov 30.
PubMed 28083395Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
PubMed 8037252National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep. 2005 Sep;28(9):1049-57. doi: 10.1093/sleep/28.9.1049. No abstract available.
PubMed 16268373Kulka RA, Schlenger WE, Fairbank JA, et al. Trauma and the Vietnam War Generation: Report of Findings From the National Vi etnam VeteransReadjustment Study. New York, NY: Brunner/Mazel; 1990.
Margolies SO, Rybarczyk B, Vrana SR, Leszczyszyn DJ, Lynch J. Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. J Clin Psychol. 2013 Oct;69(10):1026-42. doi: 10.1002/jclp.21970. Epub 2013 Apr 29.
PubMed 23629959Gellis, Les A., and Philip R. Gehrman, "Cognitive Behavioral Treatment for Insomnia in Veterans with Long-Standing Posttraumatic Stress Disorder: A Pilot Study," Journal of Aggression, Maltreatment and Trauma, Vol. 20, No. 8, 2011
Brown CA, Berry R, Schmidt A. Sleep and military members: emerging issues and nonpharmacological intervention. Sleep Disord. 2013;2013:160374. doi: 10.1155/2013/160374. Epub 2013 Jul 14.
PubMed 23956864Talbot LS, Maguen S, Metzler TJ, Schmitz M, McCaslin SE, Richards A, Perlis ML, Posner DA, Weiss B, Ruoff L, Varbel J, Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Sleep. 2014 Feb 1;37(2):327-41. doi: 10.5665/sleep.3408.
PubMed 24497661Koffel E, Farrell-Carnahan L. Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. Mil Med. 2014 May;179(5):521-8. doi: 10.7205/MILMED-D-13-00455.
PubMed 24806497Marmar CR, Schlenger W, Henn-Haase C, Qian M, Purchia E, Li M, Corry N, Williams CS, Ho CL, Horesh D, Karstoft KI, Shalev A, Kulka RA. Course of Posttraumatic Stress Disorder 40 Years After the Vietnam War: Findings From the National Vietnam Veterans Longitudinal Study. JAMA Psychiatry. 2015 Sep;72(9):875-81. doi: 10.1001/jamapsychiatry.2015.0803.
PubMed 26201054Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL, Wu RM, Schoenfeld FB. Sleep disturbances in the Vietnam generation: findings from a nationally representative sample of male Vietnam veterans. Am J Psychiatry. 1998 Jul;155(7):929-33. doi: 10.1176/ajp.155.7.929.
PubMed 9659859
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04956341
- Acronym / sponsor ID
- FWH20210106H
- Conditions
- Sleep Disturbance
- Keywords
- acupuncture, auricular acupuncture, sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Paul CrawfordUS federal agency
- Study start
- 1 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial of auricular acupuncture for sleep disturbances.
- Objective 1: Evaluate the effectiveness of a specific protocol of auricular acupuncture in the treatment of sleep disturbance among active duty and otherDoD beneficiaries.
- Objective 2: Test whether a brief course of auricular acupuncture treatments among active duty and other DoD beneficiaries with sleep disturbance willalso decrease severity of anxiety, depression, pain and improve sleep and social functioning in subgroup analysis of subjects with known or newlydiagnosed mental health disorders (e.g., anxiety disorders, depression).
- Null Hypothesis: Auricular Acupuncture has no effect on sleep disturbance.
- Alternative Hypothesis: Auricular Acupuncture reduces sleep disturbance.
Detailed description
Active duty members and DoD beneficiaries aged 18-80 years old and meeting the inclusion/exclusion criteria will be offered an opportunity to participate.They will be recruited from the clinics at 99MDG (Nellis AFB), 96MDG (Eglin AFB), and 375 MDG (Scott AFB). All of the below items are research-relatedunless marked as 'standard of care'. All visits will last approximately 30 minutes in length.
Screening Visit:
- Obtain and document signed Informed Consent document and HIPAA Authorization.
- Review past medical history to verify the inclusion/exclusion criteria
- We will record health care resource utilization to include Number of hospital or clinic visits (previous encounters) for sleep problems in the past 12 months
- Medication use (Sleep medications, stimulant medications, energy drinks at least once/week), co-morbidities, phone number, e-mail address, dateof birth, gender, race, ethnicity, highest education level, total number of children in household), Service characteristics (officer, enlisted, retired)(service branch), History of deployment (never deployed, previously deployed, number of deployments), Usual Work pattern (Day, night),
- Record whether the subject has a history of Obstructive Sleep Apnea (OSA) and whether it is treated or untreated. If treated, do they use aContinuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) machine? If patient uses CPAP/BiPAP, do they use it atleast 70% of the time as reported by patient or CPAP/BiPAP recent data pull in medical record. These questions are asked due to a possiblerelationship between OSA and sleep disturbance (3); those who have OSA and do not use a CPAP or use one infrequently need to be accounted forso as to not to confound data analysis.
- PROMIS-16 Sleep-Related Impairment Scale
Randomization:
Subjects who score a medium or severe on the PROMIS-16 (T-Score greater than or equal to 60). Sleep-Related Impairment Scale will berandomized into one of two groups and the intervention will be performed. The investigators acknowledge that any of these standard treatmentsmay be shorter or longer in duration than the duration of the study. There is no additional risk to subjects for continuing to track their sleeppatterns and mental health scores on various instruments shorter or longer than standard of care treatments. Furthermore, this study is meant tobe a pragmatic trial-there are many evidence based and not evidence based treatments for sleep disturbance that are considered standard ofcare. We seek to allow any of these treatments to proceed and evaluate the addition of auricular acupuncture as it can be applied in a clinic setting:
- Group 1: Standard treatment from Primary Care Manager (PCM) or Mental Health or both
- Group 2: Standard treatment from PCM or Mental Health or both + auricular Acupuncture
Visit 1 (0 weeks may be same day as screening visit):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
- All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 yearsor older complete the questionnaire on Survey Monkey at Visit 1, Visit 8, and Visit 10 (the dates will be on the back of the CSI-4 business card).They will be asked to have the same person complete all 3 questionnaires during the study.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16 Sleep-Related Impairment Scale (PROMIS-16)
- Measure Yourself Medical Outcome Profile (MYMOP) Initial
Visit 2 (1 week):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
Visit 3 (2 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles.
Visit 4 (3 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles -placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
Visit 5 (5 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 6 (7 Weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 7 (9 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
Visit 8 (11 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
- Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
Visit 9 (15 weeks):
- Subjects will receive study procedures according to their randomization group.
- For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
Visit 10 (23-24 Weeks):
- All subjects will take the following questionnaires via study electronic device or paper:
- PROMIS-16
- MYMOP Follow Up
- Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
CROSSOVER:
At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into theacupuncture treatment arm of the study as outlined above. This will not be part of the analysis. If a patient in the acupuncture group is still havingsymptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
All study subjects will receive a $100 gift card at the completion of the 24 weeks. Active Duty and GS employees (who are also DoD beneficiaries) mayalso receive a $100 gift card only upon completion of the appropriate off-duty employment paperwork with their supervisor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into the acupuncture treatment arm of the study as outlined above. This will not be part of the analysis. If a patient in the acupuncture group is still having symptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
| Arm | Type | Receives |
|---|---|---|
| Standard treatment from PCM or Mental Health or both + auricular acupuncture | Experimental | Device: Auricular acupuncture |
| Standard treatment from Primary Care Manager (PCM) or Mental Health or both | Placebo comparator | Other: Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female Active Duty members and DoD beneficiaries ages 18-80 with complaints of sleep disturbances.
- PROMIS-16 Sleep-Related Impairment Scale with a score of medium or severe (T-Score greater than or equal to 60).
Key exclusion criteria (8 listed)
- Patients with OSA who are prescribed CPAP/BiPAP and either do not use it or use it <70% of time per patient report.
- Investigators seek to exclude individuals with sleep-related medical or psychiatric conditions that are so severe as to render these patients inappropriate for treatment in primary care or simple mental health without psychiatry oversight or that acupuncture cannot be expected to have an effect on (e.g., thyroid disease). Specifically, exclusion criteria will include:
- Having acupuncture not related to sleep in the past 3 months
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureAuricular acupuncture treatments will be utilizing ASP needles. The needles will stay in and fall out on their own (usually 3-10 days). For some patients who are acupuncture naïve, Seirin 15mm needles will be placed and allowed to remain for 45 minutes. This option will be provided to all subjects for their first treatment. Auricular acupuncture treatment possible locations will be as defined as: Master Cerebral/Prefrontal cortex, Amygdala, Hippocampus, Hypothalamus, Point Zero, Shen Men, Insomnia 1,Insomnia 2 OR Prefrontal Cortex, Reticular formation, Pineal gland, Hypothalamus, Point zero. In acupuncture parlance, the patient will be treated with ATP plus sleep I on first visit, then the acupuncturist will continue to use that treatment for each subsequent visit with the potential to add ATP plus sleep II. Both ears will be treated unless the patient requests that one be left open. The acupuncturist may use sleep I in one ear and sleep II in the other. | Device | Standard treatment from PCM or Mental Health or both + auricular acupuncture |
| Standard treatmentStandard treatment from Primary Care Manager (PCM) or Mental Health or both | Other | Standard treatment from Primary Care Manager (PCM) or Mental Health or both |
Primary outcome
PROMIS Sleep-Related Impairment Scale
Time frame: baseline, pre-intervention
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 1 (0 weeks/same day as screening)
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 2 (1 week) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 3 (2 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 4 (3 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 5 (5 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 6 (7 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 7 (9 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 8 (11 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 9 (15 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
PROMIS Sleep-Related Impairment Scale
Time frame: visit 10 (23-24 weeks) post study visit procedures appropriate to subject randomization group
Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score
Measure Yourself Medical Outcome Profile (MYMOP) Initial
Time frame: visit 1 (0 weeks)
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time frame: visit 4 (3 weeks)
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time frame: visit 8 (11 weeks)
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time frame: visit 9 (15 weeks)
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time frame: visit 10 (23-24 weeks)
MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1.
3 secondary outcomes
Couples Satisfaction Index CSI)
Time frame: visit 1 (0 weeks)
Couples Satisfaction Index CSI)
Time frame: visit 8 (11 weeks)
Couples Satisfaction Index CSI)
Time frame: visit 10 (23-24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 25397825Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237.
- Background: PubMed 15229303Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
- Background: PubMed 28448689A Caldwell J, Knapik JJ, Lieberman HR. Trends and factors associated with insomnia and sleep apnea in all United States military service members from 2005 to 2014. J Sleep Res. 2017 Oct;26(5):665-670. doi: 10.1111/jsr.12543. Epub 2017 Apr 27.
- Background: PubMed 29931537Colvonen PJ, Straus LD, Stepnowsky C, McCarthy MJ, Goldstein LA, Norman SB. Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. Curr Psychiatry Rep. 2018 Jun 21;20(7):48. doi: 10.1007/s11920-018-0916-9.
- Background: PubMed 28083395Troxel WM, Shih RA, Pedersen ER, Geyer L, Fisher MP, Griffin BA, Haas AC, Kurz J, Steinberg PS. Sleep in the Military: Promoting Healthy Sleep Among U.S. Servicemembers. Rand Health Q. 2015 Nov 30;5(2):19. eCollection 2015 Nov 30.
- Background: PubMed 8037252Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
- Background: PubMed 16268373National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep. 2005 Sep;28(9):1049-57. doi: 10.1093/sleep/28.9.1049. No abstract available.
- BackgroundKulka RA, Schlenger WE, Fairbank JA, et al. Trauma and the Vietnam War Generation: Report of Findings From the National Vi etnam VeteransReadjustment Study. New York, NY: Brunner/Mazel; 1990.
- Background: PubMed 23629959Margolies SO, Rybarczyk B, Vrana SR, Leszczyszyn DJ, Lynch J. Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. J Clin Psychol. 2013 Oct;69(10):1026-42. doi: 10.1002/jclp.21970. Epub 2013 Apr 29.
- BackgroundGellis, Les A., and Philip R. Gehrman, "Cognitive Behavioral Treatment for Insomnia in Veterans with Long-Standing Posttraumatic Stress Disorder: A Pilot Study," Journal of Aggression, Maltreatment and Trauma, Vol. 20, No. 8, 2011
- Background: PubMed 23956864Brown CA, Berry R, Schmidt A. Sleep and military members: emerging issues and nonpharmacological intervention. Sleep Disord. 2013;2013:160374. doi: 10.1155/2013/160374. Epub 2013 Jul 14.
- Background: PubMed 24497661Talbot LS, Maguen S, Metzler TJ, Schmitz M, McCaslin SE, Richards A, Perlis ML, Posner DA, Weiss B, Ruoff L, Varbel J, Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Sleep. 2014 Feb 1;37(2):327-41. doi: 10.5665/sleep.3408.
- Individual participant dataSharing planned: No. We do not plan on sharing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, MD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture and Standard treatment in people with Sleep Disturbance, run by Paul Crawford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep-Related Impairment Scale (time frame: baseline, pre-intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956341, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.