Post Traumatic Stress DisorderNCT01862653
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
A study testing Auricular Acupuncture in people with Post Traumatic Stress Disorder and Sleep Disturbance, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Sleep Disturbance
- What is being tested?
- Auricular Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- Male gender
- veteran of OIF/OEF
- comorbid mental health problems such as depression, anxiety are allowed
- self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares.
- sleep disturbances must have started after a deployment
Who cannot join
- Axis I mental disorders incompatible with active military service
- History of moderate to severe traumatic brain injury
- Sleep Apnea
- Current use of Continuous Positive Airway Pressure Devices
- Significant Co-morbid conditions (heart, lung, liver disease, etc.)
- Other treatment programs that involve cognitive processing therapy
Show all 9Show fewer
- No concurrent use of acupuncture during study
- taking any anticoagulation medication
- essential tremors
Trial locations and contacts
1 site in 1 country.
United States1 site
Overcoming Adversity and Stress and Injury Support Clinic
San Diego, California, 92106
About this study
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.
- Conditions
- Post Traumatic Stress Disorder, Sleep Disturbance
- Being tested
- Auricular Acupuncture
- Keywords
- Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture
- Medical subject headings
- Stress Disorders, Post-Traumatic, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureDevice
Subjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture | Experimental | An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group. Receives: Device: Auricular Acupuncture |
| Control | No intervention | The control group is a wait-list control group and will be offered the auricular acupuncture intervention after the study is complete. No intervention will be performed on control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective Sleep Times
Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month.
Measured: Baseline (upon entering study) and at one month
Change in Subjective Sleep Times
Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month
Measured: Baseline (upon entering study) and at one month
Acceptability of Acupuncture as a Treatment for Sleep Disturbance
Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question.
Measured: One month
Secondary outcomes (4)
Change in Sleep Quality
Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline and at one month
Measured: Baseline (upon entering study) and at one month
Change in Sleep Quality
Change in sleep quality ratings will also be measured by the consensus sleep diary sleep quality ratings at baseline and at one month.
Measured: Baseline (upon entering study) and at one month
Change in Depression
Change in depression will be measured by Patient Health Questionnaire, version 9 (PHQ-9) scores at baseline, at week 3, and at week 5.
Measured: Baseline (upon entering study) and at week 3 & at week 5
Change in Post Traumatic Stress Disorder Symptoms
Change in Post Traumatic Stress Disorder Symptoms will be measured by the Post Traumatic Stress Disorder Checklist at baseline, at week 3, and at week 5.
Measured: Baseline (upon enterning the study) and week 3 & at week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Heather C King, MSN, Principal investigator, Naval Medical Center San Diego/ University of San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862653
- Sponsor's protocol ID
- NMCSD.2012.0053
- Other IDs
- HT9404-12-1-TS15(N12-P15)
- Status last verified
- Sep 2014
- First submitted
- 6 May 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01862653
- Acronym / sponsor ID
- NMCSD.2012.0053
- Conditions
- Post Traumatic Stress Disorder, Sleep Disturbance
- Keywords
- Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- 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.
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Experimental | Device: Auricular AcupunctureAn insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group. |
| Control | No intervention | –The control group is a wait-list control group and will be offered the auricular acupuncture intervention after the study is complete. No intervention will be performed on control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-50 years
- Male gender
- veteran of OIF/OEF
- comorbid mental health problems such as depression, anxiety are allowed
- self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares.
Key exclusion criteria (9 listed)
- Axis I mental disorders incompatible with active military service
- History of moderate to severe traumatic brain injury
- Sleep Apnea
- Current use of Continuous Positive Airway Pressure Devices
- Significant Co-morbid conditions (heart, lung, liver disease, etc.)
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 AcupunctureSubjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture. | Device | Auricular Acupuncture |
Primary outcome
Change in Objective Sleep Times
Time frame: Baseline (upon entering study) and at one month
Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month.
Change in Subjective Sleep Times
Time frame: Baseline (upon entering study) and at one month
Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month
Acceptability of Acupuncture as a Treatment for Sleep Disturbance
Time frame: One month
Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question.
4 secondary outcomes
Change in Sleep Quality
Time frame: Baseline (upon entering study) and at one month
Change in Sleep Quality
Time frame: Baseline (upon entering study) and at one month
Change in Depression
Time frame: Baseline (upon entering study) and at week 3 & at week 5
Change in Post Traumatic Stress Disorder Symptoms
Time frame: Baseline (upon enterning the study) and week 3 & at week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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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.
Heather C King, MSN principal investigator
Naval Medical Center San Diego/ University of San Diego
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 in people with Post Traumatic Stress Disorder and Sleep Disturbance, run by United States Naval Medical Center, San Diego 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 1 Oct 2014. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Objective Sleep Times (time frame: Baseline (upon entering study) and at one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2014.