An interventional study of CBTI app intervention and Physical Activity intervention in Chronic Insomnia, sponsored by Northeastern University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Northeastern 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 589th largest by enrollment of the 854 interventional ones that give a count, is one of 43 that started in 2018, is one of 575 with no phase, and was the 429th 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: 21 Years to 65 Years · all sexes · no healthy volunteers.
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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. 43 started in 2018.
This study's enrollment of 33 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.
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185 of 902 have an industry lead sponsor. The 10 most frequent:
Northeastern University is the lead sponsor of 55 studies on the registry; 19 are open to participants now.
Northeastern University has 1 study 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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Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups of veterans with insomnia: (1) one group that completes a 6 week self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will have better subjective and objective sleep, higher step counts, and better functional health and social and community integration than those receiving CBTI alone. This pilot work will provide evidence to guide the design of a future randomized controlled trial.
To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep, physical activity, functioning, or social engagement over and above self-management use of a CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with chronic, functionally impairing insomnia to either (1) a self-management-based use of an app based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA) that includes PA monitoring (via a Fitbit device) with individualized goal-setting to encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will attempt to get all participants to at least the typical 10,000 daily steps goal cited as a strong predictor of positive health outcomes (Choi, Pak, \& Choi, 2007). The investigators will tailor the step goals based on the person's initial level of daily steps, and increment step goals weekly to maximize motivation and enhance the likelihood that the participant can meet the goal.
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:
Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide
Behavioral: CBTI app intervention
Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts
Behavioral: CBTI app intervention · Behavioral: Physical Activity intervention
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
Self-management guided motivation to increase physical activity by increasing daily step counts
Insomnia Severity Index Total Score
Total score on the Insomnia Severity Index
Time frame: 6 weeks (Immediate post-intervention)
Pittsburgh Sleep Quality Index Total Score
Total score on the Pittsburgh Sleep Quality Index Total Score
Time frame: 6 weeks (Immediate post-intervention)
Objective Sleep Efficiency
Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor
Time frame: 6 weeks (Immediate post-intervention)
Daily step counts
Daily step counts as measured by a Fitbit device
Time frame: 6 weeks (Immediate post-intervention)
Functional Outcomes of Sleep
Functional Outcomes of Sleep Questionnaire total score (10 item version)
Time frame: 6 weeks (Immediate post-intervention)
Social Engagement
Total score on the Lubben Social Network Scale
Time frame: 6 weeks (Immediate post-intervention)
Community Engagement
Total score on the Community Integration Questionnaire
Time frame: 6 weeks (Immediate post-intervention)
Physical Functional Health
Physical Function score from the Veteran's RAND-12 scale
Time frame: 6 weeks (Immediate post-intervention)
Mental Functional Health
Mental Function score from the Veteran's RAND-12 scale
Time frame: 6 weeks (Immediate post-intervention)
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2019, 16 months.
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 16 months is close to 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.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
Northeastern University