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Recruiting Not applicable Interventional

Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study

ClinicalTrials.gov ID: NCT07156383

Public ClinicalTrials.gov record NCT07156383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 8:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.

Study identification

NCT ID
NCT07156383
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Notre Dame
Other
Enrollment
115 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 28, 2025
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027
Last update posted
Apr 22, 2026

2025 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Notre Dame Notre Dame Indiana 46556 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07156383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 22, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07156383 live on ClinicalTrials.gov.

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