An interventional study of Shift Worker Intervention for Sleep Health in Shift Work Type Circadian Rhythm Sleep Disorder and Insomnia, Psychophysiological, sponsored by Oregon State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Oregon State University · Not applicable, Interventional, and Treatment
Among 902 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 145 open to participants now, 182 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.
Among the 902 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 414th largest by planned enrollment of the 854 interventional ones that give a count, is one of 56 that started in 2025, is one of 575 with no phase, reaches primary completion later than 113 of the 181 other live ones, and was the 746th registered.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →145 of the 902 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
University of Pittsburgh · Sites in United States
Eight Sleep Inc. · Sites in United States
Proactive Life Inc · Sites in United States
Spectrum Clinical Research, LLC · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 386 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 204 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
902 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 103 · Phase 3 77 · Phase 4 79
First in 1997; this study’s year is marked. 56 started in 2025.
This study's planned enrollment of 60 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 854 interventional studies, 72 across the 48 observational. Of the 660 that completed or were terminated, 242 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
185 of 902 have an industry lead sponsor. The 10 most frequent:
Oregon State University is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Oregon State University has 2 studies filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
78 of the studies in Sleep Initiation and Maintenance Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06655883Phase 3Merck Sharp & Dohme LLCA Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) | 2027-06-24 |
| NCT07336277Phase 3Emory UniversitySleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients | 2027-07 |
| NCT06953869Phase 3Vanda PharmaceuticalsEvaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | 2027-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
Among the 902 studies in Sleep Initiation and Maintenance Disorders with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia. Other Names: Cognitive Behavioral Therapy for Insomnia
Behavioral: Shift Worker Intervention for Sleep Health
Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point.
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
Also known as: SWISH
Retention Rate
Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\]
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Session Attendance
For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\]
Time frame: 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.
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
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
Time frame: 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.
Time frame: 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)
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Acceptability of Study Procedures and SWISH
Enrollment percent, number of study assessment visits completed.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Plan to share: Yes — De-identified data may be uploaded to a data repository to make it accessible for publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available within 2 years after the publication of the results pertaining to the primary aims and will be available for at least 2 years.
Access criteria: Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with the principal investigator.
Started Apr 2025 (actual). Primary completion is estimated for Sep 2027, 29 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 29 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Sleep Initiation and Maintenance Disorders →
Oregon State University