Enhancing sleep health in midlife adults
Sleep Health Enhancement in Midlife Adults
This study is testing a new program to help midlife adults improve their sleep quality to see if it can also lower their risk of developing Alzheimer's disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 64 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06311500 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate a comprehensive sleep health intervention designed to improve sleep quality in midlife adults aged 45-64. The intervention focuses on enhancing sleep health as a preventive measure against Alzheimer's disease (AD). Researchers will assess the feasibility, acceptability, and treatment effects of the intervention on participants' sleep health. The study targets individuals who report poor sleep quality and are at risk for cognitive decline.
Who should consider this trial
Good fit: Ideal candidates for this study are midlife adults aged 45-64 who report poor sleep quality and have no significant sleep disorders.
Not a fit: Patients with untreated sleep disorders, severe mental illness, or significant substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could delay or prevent the onset of Alzheimer's disease in midlife adults by improving their sleep health.
How similar studies have performed: While there is emerging interest in sleep health interventions for cognitive decline, this specific approach targeting midlife adults is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 45-64 years old * ≤ 7 on the RU-SATED self-report questionnaire * MMSE ≥25 and AD8 \<3 Exclusion Criteria: * Known untreated sleep disorder (such as sleep apnea or restless leg syndrome) * \>3 on the STOP BANG indicating increased risk of sleep apnea * Increased risk of restless legs syndrome on RLS-Diagnosis Index * Evidence of circadian rhythm sleep-wake disorder * Evidence of parasomnia * Regular use (\>2x/week) of prescription or over-the-counter medications to improve sleep * Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9) * Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety * Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria * History of nervous system disorder such as stroke or Parkinson's disease * Severe mental illness such as schizophrenia or bipolar disorder * Current or history (within 5 years) of shift work including hours of midnight-4am * Is currently receiving a behavioral sleep health intervention
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Catherine Siengsukon, PhD
- Email: csiengsukon@kumc.edu
- Phone: 913-588-6913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.