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

RecruitingNAAges 18 Years - anyAllUniversity of Notre Dame
NCT07156383 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Cognitive Behavioral Therapy for Insomnia
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Where

1 site
University of Notre Dame
Notre Dame, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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