Clinical trial NCT05968820: Sleep Health Enhancement in Older Adults to Address Frailty
Official title: Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Frailty
Keywords: Sleep Health
Older Adults
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 Criteria:

* ≥65 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
* 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

Primary outcomes:
measure: 6-item Acceptability Scale
timeFrame: 6 week
measure: semi-standardized qualitative interview
timeFrame: 6 week
measure: Tilburg Frailty Indicator
timeFrame: baseline, 6 week and 12 week reassessments
measure: WHOQOL-BREF
timeFrame: baseline, 6 week and 12 week reassessments
measure: Ru_SATED sleep health composite
timeFrame: baseline, 6 week and 12 week reassessments
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline, 6 week and 12 week reassessments
measure: Epworth Sleepiness Scale
timeFrame: baseline, 6 week and 12 week reassessments
measure: Dysfunctional Beliefs About Sleep
timeFrame: baseline, 6 week and 12 week reassessments
measure: Sleep Self-Efficacy
timeFrame: baseline, 6 week and 12 week reassessments
measure: Actigraphy
timeFrame: baseline, 6 week and 12 week reassessments
Other outcomes:
measure: Timed Up and Go
timeFrame: baseline, 6 week and 12 week reassessments
measure: 15 ft walk test
timeFrame: baseline, 6 week and 12 week reassessments
measure: 6-Minute Walk Test (6MWT)
timeFrame: baseline, 6 week and 12 week reassessments
measure: Grip strength of the dominant and nondominant hand
timeFrame: baseline, 6 week and 12 week reassessments
measure: The Continuous Performance Test (CPT)
timeFrame: baseline, 6 week and 12 week reassessments
measure: The Stroop Test
timeFrame: baseline, 6 week and 12 week reassessments
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: baseline, 6 week and 12 week reassessments
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
state: Kansas
Study officials:
References: