Sleep Health Enhancement in Older Adults to Address Frailty

Last updated: September 4, 2024
Sponsor: University of Kansas Medical Center
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Sleep Health Enhancement Intervention

Clinical Study ID

NCT05968820
STUDY00150428
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥65 years old

  • ≤ 7 on the RU-SATED self-report questionnaire

  • MMSE ≥25 and AD8 <3

Exclusion

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

  • Evidence 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 improvesleep

  • Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severedepression or endorse 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 tosevere anxiety

  • Self-report of current or history (up to 2 years) of drug or alcohol abuse based onthe DSM-V 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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Sleep Health Enhancement Intervention
Phase: 1
Study Start date:
September 12, 2023
Estimated Completion Date:
August 30, 2024

Connect with a study center

  • University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

    Kansas City, Kansas 66160
    United States

    Site Not Available

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