Status:
NOT_YET_RECRUITING
Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study
Lead Sponsor:
University of Notre Dame
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07156383
Start Date
September 1 2025
End Date
August 31 2027
Last Update
September 5 2025
Active Locations (1)
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1
University of Notre Dame
Notre Dame, Indiana, United States, 46556