Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study (NCT07156383)
Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Notre Dame β Notre Dame, Indiana
Age range: 18 Years
π§ͺ Interventions in This Study
- Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL)
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- University of Notre Dame β Notre Dame, Indiana
π Contact the Study Coordinator
Phone: (574) 631-5914
Email: ivargas@nd.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Insomnia
- The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients β Philadelphia, Pennsylvania
- Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks β Montreal, Quebec
- Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapyβ’ in Patients With Sleep Deprivation and Chronic Insomnia β Aventura, Florida
- Insomnia Behavioral Intervention Study β Philadelphia, Pennsylvania
- Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients β Surrey, British Columbia
- Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0 β Durham, North Carolina
Explore by condition: All Chronic Insomnia clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.