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NCT07156383 · ClinicalTrials.gov registry record · NA
Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study
A NA study, sponsored by University of Notre Dame.
- Recruiting
- Registry status
- NA
- Development phase
- 115
- Enrollment target
NCT07156383 is a NA study that is actively recruiting participants, run by University of Notre Dame. The registered enrollment target is 115 participants.
The verdict
NCT07156383, a NA study, is actively recruiting participants, sponsored by University of Notre Dame.
- RECRUITING
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07156383
The ClinicalTrials.gov registry entry for NCT07156383 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Notre Dame, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT07156383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07156383 about?
NCT07156383 is a clinical study titled "Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study". The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stre...
What is the current status of trial NCT07156383?
This trial is currently recruiting. It is a NA study. The enrollment target is 115 participants. The study started on 2025-09-29. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07156383?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT07156383?
This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.
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