Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2024-02-13
2025-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Sleep health enhancement intervention
4 weekly visits of education and strategies to enhance sleep health
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.
No interventions assigned to this group
Interventions
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Sleep health enhancement intervention
4 weekly visits of education and strategies to enhance sleep health
Eligibility Criteria
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Inclusion Criteria
* ≤ 7 on the RU-SATED self-report questionnaire
* MMSE ≥25 and AD8 \<3
Exclusion Criteria
* \>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
45 Years
64 Years
ALL
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00151143
Identifier Type: -
Identifier Source: org_study_id