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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: Recruiting NA study, sponsored by University of Notre Dame.

NCT07156383 is a NA study that is actively recruiting participants, run by University of Notre Dame. The registered enrollment target is 115 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Total score on the Insomnia Severity Index (ISI), which ranges from 0-28. Higher scores indicate greater insomnia severity, while lower scores indicate less insomnia severity.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy for Insomnia

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2025-09-29
Est. Completion 2027-08-31
Phase NA
University of Notre Dame

13 total trials

What NCT07156383 shows while recruiting

NCT07156383 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia is the first listed.

NCT07156383 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT07156383's enrollment target sits among peer trials

115 810th of 2000 higher than 1,190 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07156383, the US trial registry maintained by the National Library of Medicine. NCT07156383 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.