Notre Dame, INNCT07156383Now EnrollingIRB Ready

Chronic Insomnia Clinical Trial in Notre Dame, IN

Access cutting-edge chronic insomnia treatment through this clinical trial at a research site in Notre Dame. Study-provided care at no cost to qualified participants.

Sponsored by University of Notre Dame

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Expert Care in Notre Dame

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic insomnia treatment provided free

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Notre Dame

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Notre Dame site if eligible
  4. 4Begin participation

About This Chronic Insomnia Study in Notre Dame

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). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.

Sponsor: University of Notre Dame

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Notre Dame?

Yes, this clinical trial (NCT07156383) has an active research site in Notre Dame, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Insomnia Treatment Options in Notre Dame, IN

If you're searching for chronic insomnia treatment options in Notre Dame, IN, this clinical trial (NCT07156383) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Notre Dame research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic insomnia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic insomnia clinical trials near you to find additional studies recruiting in your area.

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