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

NCT07156383 | Recruiting

• 1 other identifier: 25-01-9063
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Insomnia

Keywords

Sleep Initiation and Maintenance Disorders; Insomnia Disorder; Sleep Disorders; Cortisol; Sleep Deprivation

Outcome Measures

Primary Outcomes (4)

• Insomnia Symptoms

  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.

  From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

• Sleep Continuity Disturbance

  Mean sleep latency, wake after sleep onset, and early morning awakenings (in minutes assessed via daily sleep diaries).

  From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

• Total Sleep Time

  Mean sleep duration (in minutes) assessed via daily sleep diaries

  From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

• HPA-Axis Functioning

  Salivary cortisol assessed in three ways: hair (chronic stressor exposure), at-home saliva (basal cortisol), and saliva in response to an in-lab stressor (stress reactivity).

  From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

Study Arms (2)

4-Week CBT-I

EXPERIMENTAL

Participants in this arm will receive 4 weeks of CBT-I.

Behavioral: Cognitive Behavioral Therapy for Insomnia

10-Week CBT-I

EXPERIMENTAL

Participants in this arm will receive 10 weeks of CBT-I.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first line treatment for Insomnia. Participants will receive weekly CBT-I during which they will receive the tools to improve their sleep.

10-Week CBT-I; 4-Week CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18-years-old
• Speaks English
• Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)

You may not qualify if:

• Sleep disorders other than Insomnia
• Endocrine disorders
• Extreme sleep schedule (i.e. shift workers)
• Currently taking sleep medication
• Currently taking medication for endocrine dysfunction
• Currently taking medication that interferes with sleep or cortisol levels
• Excessive alcohol/substance use or AUD/SUD
• Serious mental illness
• Chronic medical conditions (which may be exacerbated by sleep restriction)
• Pregnant or nursing women
• Women in the peri-menopausal stage due to irregular menses and fluctuations in sex hormones.

Sponsors & Collaborators

• University of Notre Dame: lead

Study Sites (1)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Sleep Deprivation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Ivan Vargas

CONTACT

574-631-5914; ivargas@nd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A within, between subjects design will be used with a four week run-in period (to establish a baseline) prior to the intervention phase (randomly assigned to one of two active interventions that are administered in parallel).

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 5, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: De-identified IPD will be made available indefinitely upon publication of the primary study results.

Locations

US (1)