Restoring everyday health and wellbeing by improving sleep
Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia
This study will try Cognitive Behavioral Therapy for Insomnia (CBT-I) in adults with chronic insomnia to see if better sleep changes stress-hormone (cortisol) patterns and improves daytime health, especially for people who sleep less than six hours a night.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Notre Dame Academic / other |
| Locations | 1 site (Notre Dame, Indiana) |
| Trial ID | NCT07156383 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit adults with chronic insomnia and split them into two groups based on typical sleep duration (less than 6 hours versus 6 or more hours). All participants will receive CBT-I and complete four in-lab assessments that include measures of cortisol and HPA-axis functioning alongside objective and self-reported sleep measures. The study compares short and non-short sleepers and contrasts shorter versus longer CBT-I timeframes to see which aspects of sleep (consolidation versus duration) relate to cortisol change. Results will clarify whether improvements in sleep lead to measurable changes in stress-hormone regulation and daytime functioning.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults (18+) who meet DSM-5 criteria for Insomnia Disorder and can attend in-person visits, with interest in whether their typical sleep is under or over six hours per night.
Not a fit: People with other sleep disorders, endocrine disorders, extreme/shift work schedules, those taking sleep- or hormone-affecting medications, pregnant or nursing women, peri-menopausal women, or those with serious mental illness or substance use disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help tailor insomnia treatment to reduce stress-hormone dysregulation and improve sleep and daytime functioning for patients.
How similar studies have performed: CBT-I is a well-established and effective treatment for insomnia, but prior evidence that CBT-I consistently normalizes cortisol or HPA-axis function is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Notre Dame, Indiana
- University of Notre Dame — Notre Dame, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Ivan Vargas
- Email: ivargas@nd.edu
- Phone: 574-631-5914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.