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Sleep Health Enhancement in Midlife Adults

Sleep Health Enhancement in Midlife Adults

Recruiting
45-64 years
All
Phase 1/2

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Overview

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

Eligibility

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 details
    Sleep Health
    Midlife Adults

NCT06311500

University of Kansas Medical Center

17 January 2025

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