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New treatment option for Chronic Insomnia
Official title Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study
ClinicalTrials.gov ID: NCT07156383
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Notre Dame, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Notre Dame, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.