Sleep Health Enhancement in Midlife Adults
Purpose
Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults
Conditions
- Sleep Health
- Midlife Adults
Eligibility
- Eligible Ages
- Between 45 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sleep Health Enhancement Intervention |
4 weekly visits using Zoom video conferencing consisting of education and strategies to enhance sleep health with each visit lasting about 60 minutes. |
|
|
No Intervention Wait-List Control Group |
People in the wait-list group will continue with their usual activities for 4 weeks and then start the sleep health enhancement intervention. |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center