Sleep Health Enhancement in Older Adults to Address Frailty

NCT05968820 | Completed Phase 1

• 1 other identifier: STUDY00150428
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

Sleep Health; Older Adults

Outcome Measures

Primary Outcomes (5)

• 6-item Acceptability Scale

  5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction

  6 week

• semi-standardized qualitative interview

  Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes

  6 week

• Tilburg Frailty Indicator

  The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.

  baseline, 6 week and 12 week reassessments

• WHOQOL-BREF

  The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.

  baseline, 6 week and 12 week reassessments

• Ru_SATED sleep health composite

  Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires. The domains will be summed to create the composite sleep health score ranging from 0-6 with a higher score indicating better sleep health.

  baseline, 6 week and 12 week reassessments

Secondary Outcomes (5)

• Pittsburgh Sleep Quality Index

  baseline, 6 week and 12 week reassessments

• Epworth Sleepiness Scale

  baseline, 6 week and 12 week reassessments

• Dysfunctional Beliefs About Sleep

  baseline, 6 week and 12 week reassessments

• Sleep Self-Efficacy

  baseline, 6 week and 12 week reassessments

• Actigraphy

  baseline, 6 week and 12 week reassessments

Other Outcomes (7)

• Timed Up and Go

  baseline, 6 week and 12 week reassessments

• 15 ft walk test

  baseline, 6 week and 12 week reassessments

• 6-Minute Walk Test (6MWT)

  baseline, 6 week and 12 week reassessments

Study Arms (2)

Sleep Health Enhancement Intervention

EXPERIMENTAL

The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention.

Behavioral: Sleep Health Enhancement Intervention

Wait-List Control Group

NO INTERVENTION

The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment.

Interventions

Sleep Health Enhancement Intervention BEHAVIORAL

The program is based on principles from CBT-I (time in bed restriction, stimulus control, relaxation techniques, sleep education) and includes behavioral strategies to entrain circadian rhythm, strengthen sleep homeostasis, reduce hyperarousal, and sleep hygiene techniques. Self-Determination Theory (SDT) and Social Cognitive Theory (SCT) will serve as the theoretic framework for behavior change techniques (BCT) threaded through the sleep health enhancement intervention. Participants will maintain a sleep diary during the program to aid in tailoring the program, self-monitoring of behavior, and feedback of behavior. Goals will be set by the participant at each session and reviewed at subsequent sessions, and motivational interviewing principles will be incorporated.

Sleep Health Enhancement Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years old
• ≤ 7 on the RU-SATED self-report questionnaire
• MMSE ≥25 and AD8 \<3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

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

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 1, 2023
• Study Start: September 12, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)