Shift Work Type Circadian Rhythm Sleep DisorderSWISHNCT06384742
Shift Worker Intervention for Sleep Health
A study testing Shift Worker Intervention for Sleep Health in people with Shift Work Type Circadian Rhythm Sleep Disorder and Insomnia, Psychophysiological, run by Oregon State University at 1 site in United States.
Trial summary
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shift Work Type Circadian Rhythm Sleep Disorder, Insomnia, Psychophysiological
- What is being tested?
- Shift Worker Intervention for Sleep Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 15 Jan 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Any gender; Ages 18-65
- Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
- Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=2 nights/week) and have worked shift work >=2 nights/week for at least 3 months
- Expect to have a shift work schedule >=2 nights/week over the next 6 months
- endorse poor sleep, as evidenced by T-score >=60 on the PROMIS Sleep Disturbance OR Sleep-Related Impairment measure
- Have daily access to the internet on a smartphone, table, or computer; and
- Can read and write in English.
Who cannot join
- Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
- Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
- Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
- Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liudmyla Kozii, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Oregon State University
Corvallis, Oregon, 97331-1102
Jessee Dietch, PhD, 541-737-1358, jessee.dietch@oregonstate.edu
Jessee Dietch, PhD
About this study
Official title: Developing a Sleep Health Intervention for Shift Workers
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.
Read the detailed description
Night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. Participants will be randomized to either SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. The therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.
- Being tested
- Shift Worker Intervention for Sleep Health
- Keywords
- insomnia, shift work, nurse, sleep psychology, behavioral sleep medicine, circadian rhythm
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shift Worker Intervention for Sleep HealthBehavioural
Also called SWISH
SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across nine approximately weekly sessions that range in length from 15-60 minutes
| Study group | Role | What they receive |
|---|---|---|
| SWISH | Experimental | SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia.
Other Names:
Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Shift Worker Intervention for Sleep Health |
| WLC | No intervention | Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
Measured: At the post-treatment assessment (occurring at approximately 12 weeks)
Session Attendance
For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
Measured: At the post-treatment assessment (occurring at approximately 12 weeks)
Implementation Assessment Measure
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
Measured: At the post-treatment assessment (occurring at approximately 12 weeks)
Secondary outcomes (12)
Change in PROMIS Sleep Related Impairment
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during wake. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Sleep Disturbances
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during sleep. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep disturbances.
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Patient Adherence
Self-rated adherence to recommendations (items added to standard sleep diary)
Measured: At the post-treatment assessment (occurring at approximately 12 weeks)
Acceptability of Study Procedures and SWISH
Enrollment percent, number of study assessment visits completed.
Measured: After treatment is completed (occurring at approximately 12 weeks)
Change in Fatigue Severity Scale
Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue
Measured: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a validated 8-item self-report measure used to assess sleepiness during waking hours, with higher numbers representing greater sleepiness.
Measured: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep efficiency on modified Consensus Sleep Diary
Sleep efficiency percent will be derived from modified version of the Consensus Sleep Diary; averaged across available days at each time point (up to 2 weeks)
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep duration on modified Consensus Sleep Diary
Sleep duration in hours will be derived from modified version of the Consensus Sleep Diary; averaged across available days at each time point (up to 2 weeks)
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep efficiency
Sleep efficiency percent will be derived from Fitbit Sense and averaged across available days at each time point (up to 2 weeks)
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep duration
Hours of sleep duration will be derived from Fitbit Sense and averaged across available days at each time point (up to 2 weeks)
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Emotional Distress - Depression
A validated 8-item Common Data Element measures which assess depressive symptom severity. Validated questionnaire; total raw score range between 8-40, with higher numbers indicating greater depressive symptomatology.
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in cognition
Cognitive performance on the Joggle Research Cognitive Battery selected subtests including Psychomotor Vigilance Task (PVT). T scores (higher is better) will be reported.
Measured: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start28 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (84)Papers the sponsor has linked to this study.
- Other trials for Shift Work Type Circadian Rhythm Sleep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jessee Dietch, Oregon State University
- Investigators
- Jessica Dietch, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384742
- Sponsor's protocol ID
- HE-2023-505
- Other IDs
- K23HL157698
- Acronym
- SWISH
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be uploaded to a data repository to make it accessible for publication.
Publications
Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16.
PubMed 29247501Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22.
PubMed 19387517Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8.
PubMed 19357324Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29.
PubMed 22645325Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9.
PubMed 23403128Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015.
PubMed 26491356Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11.
PubMed 26498240Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.
PubMed 11600731Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.
PubMed 25030030Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7.
PubMed 19268039Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016.
PubMed 24316614Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091.
PubMed 28581264Angerer P, Schmook R, Elfantel I, Li J. Night Work and the Risk of Depression. Dtsch Arztebl Int. 2017 Jul 16;114(24):404-411. doi: 10.3238/arztebl.2017.0404.
PubMed 28669378Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.
PubMed 25576495Bureau of Labor Statistics. Standard occupational classification groups. 2018. Retrieved from bls.gov/soc/
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Sleep Health Intervention for Shift Workers
- ClinicalTrials.gov ID
- NCT06384742
- Acronym / sponsor ID
- SWISH / HE-2023-505
- Keywords
- insomnia, shift work, nurse, sleep psychology, behavioral sleep medicine, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 25 Apr 2024 (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.
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.
Detailed description
Night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. Participants will be randomized to either SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. The therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWISH | Experimental | Behavioral: Shift Worker Intervention for Sleep HealthSWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia. Other Names: Cognitive Behavioral Therapy for Insomnia |
| WLC | No intervention | –Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Any gender; Ages 18-65
- Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
- Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=2 nights/week) and have worked shift work >=2 nights/week for at least 3 months
- Expect to have a shift work schedule >=2 nights/week over the next 6 months
Key exclusion criteria (4 listed)
- Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
- Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
- Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
- Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"
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 |
|---|---|---|
| Shift Worker Intervention for Sleep HealthAlso: SWISHSWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across nine approximately weekly sessions that range in length from 15-60 minutes | Behavioural | SWISH |
Primary outcome
Retention Rate
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
Session Attendance
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
Implementation Assessment Measure
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
12 secondary outcomes
Change in PROMIS Sleep Related Impairment
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Sleep Disturbances
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Patient Adherence
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Acceptability of Study Procedures and SWISH
Time frame: After treatment is completed (occurring at approximately 12 weeks)
Change in Fatigue Severity Scale
Time frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in Epworth Sleepiness Scale
Time frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep efficiency on modified Consensus Sleep Diary
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep duration on modified Consensus Sleep Diary
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep efficiency
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep duration
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Emotional Distress - Depression
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in cognition
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 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 2 May 2025.
- Background: PubMed 29247501Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16.
- Background: PubMed 19387517Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22.
- Background: PubMed 19357324Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8.
- Background: PubMed 22645325Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29.
- Background: PubMed 23403128Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9.
- Background: PubMed 26491356Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015.
- Background: PubMed 26498240Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11.
- Background: PubMed 11600731Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.
- Background: PubMed 25030030Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.
- Background: PubMed 19268039Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7.
- Background: PubMed 24316614Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016.
- Background: PubMed 28581264Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091.
- Individual participant dataSharing planned: Yes. De-identified data may be uploaded to a data repository to make it accessible for publication.
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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.
Liudmyla Kozii, MD, MPH contact
Jessica Dietch, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shift Worker Intervention for Sleep Health in people with Shift Work Type Circadian Rhythm Sleep Disorder and Insomnia, Psychophysiological, run by Oregon State University 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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?
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?
Contact Jessica R Dietch, PhD (5417371358, jessee.dietch@oregonstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: At the post-treatment assessment (occurring at approximately 12 weeks)). 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?
On the ClinicalTrials.gov record for NCT06384742, which also lists 84 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 2 May 2025.