Status:
COMPLETED
Sleep Health Enhancement in Older Adults to Address Frailty
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Frailty
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief 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 c...
Eligibility Criteria
Inclusion
- ≥65 years old
- ≤ 7 on the RU-SATED self-report questionnaire
- MMSE ≥25 and AD8 \<3
Exclusion
- 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 improve sleep
- Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression 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 to severe anxiety
- Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the 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
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05968820
Start Date
September 12 2023
End Date
August 30 2024
Last Update
September 19 2024
Active Locations (1)
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1
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, United States, 66160