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

Part of paid clinical trials in Notre Dame, Indiana.

Sponsor
University of Notre Dame
Study ID
NCT07156383
Status
Recruiting
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Conditions

  • Chronic Insomnia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
115 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4-Week CBT-I
    Participants in this arm will receive 4 weeks of CBT-I.
  • Experimental: 10-Week CBT-I
    Participants in this arm will receive 10 weeks of CBT-I.

Primary Outcome Measure

Insomnia Symptoms [ Time Frame: 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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Notre DameNotre DameIndiana46556
Ivan Vargas
[email protected]
574-631-5914
Emma Janes
[email protected]
Ivan Vargas, PhD (PRINCIPAL_INVESTIGATOR)

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