Restoring everyday health and wellbeing by improving sleep
Official title: Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia
Run by University of Notre Dame · NCT07156383 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 115 (estimated) |
| Sponsor | University of Notre Dame Academic / other |
| Locations | 1 site (Notre Dame, Indiana) |
| Status | Recruiting |
| Started | September 29, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07156383 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University of Notre Dame
Notre Dame, Indiana, United States Recruiting
Study contacts
- Study coordinator: Ivan Vargas
- Email: ivargas@nd.edu
- Phone: 574-631-5914
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
A smart look at common sleep meds for insomnia
This trial tests how well and how safely widely used sleep medicines and OTCs work for adults with insomnia and which might be best overall.
-
Transcranial alternating current stimulation for generalized anxiety disorder and chronic insomnia
This study will try 20 sessions of transcranial alternating current stimulation (tACS) with the Nexalin device to see if it improves anxiety and sleep in adults with generalized anxiety disorder and chronic insomnia.
-
Adding yoga to usual care for adults with chronic insomnia
This trial will test whether doing a structured yoga program alongside usual care helps adults (18–65) with chronic insomnia sleep better than usual care alone.
-
SWELL cognitive behavioral therapy program for chronic insomnia in older Veterans
This project will try two ways of rolling out SWELL, a five-session CBT for chronic insomnia, to help older Veterans get and benefit from treatment.
-
Brief group Acceptance and Commitment Therapy (ACT-i) for adults with chronic insomnia
This project will test whether a short, group Acceptance and Commitment Therapy program (ACT-i) helps adults aged 18–59 with chronic insomnia compared with an attentional control program.
-
Frontal vibration to improve sleep and memory in chronic insomnia
This study will test whether gentle low‑intensity vibrations applied to the forehead help adults with chronic insomnia sleep better and improve memory.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.