Sleep Health Enhancement in Older Adults to Address Frailty

Study Overview
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Brief Summary
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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.

Official Title
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Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty

Conditions
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Frailty

Intervention / Treatment
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* Behavioral: Sleep Health Enhancement Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. ≥65 years old, 2. ≤ 7 on the RU-SATED self-report questionnaire, and 3. MMSE ≥25 and AD8 <3. Exclusion Criteria: 1. Known untreated sleep disorder (such as sleep apnea or restless leg syndrome); 2. >3 on the STOP BANG indicating increased risk of sleep apnea; 3. Increased risk of restless legs syndrome on RLS-Diagnosis Index; 4. Evidence of circadian rhythm sleep-wake disorder; 5. Evidence of parasomnia; 6. Regular use (>2x/week) of prescription or over-the-counter medications to improve sleep; 7. 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); 8. Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety; 9. Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria; 10. History of nervous system disorder such as stroke or Parkinson's disease; 11. Severe mental illness such as schizophrenia or bipolar disorder; 12. Current or history (within 5 years) of shift work including hours of midnight-4am; and 13. Is currently receiving a behavioral sleep health intervention.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Health Enhancement Intervention<br>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<br>* 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.<br>|
| No Intervention: Wait-List Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 6 week and 12 week reassessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of >5 indicates poor sleep quality. | baseline, 6 week and 12 week reassessments | 
| Epworth Sleepiness Scale | Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. | baseline, 6 week and 12 week reassessments | 
| Dysfunctional Beliefs About Sleep | This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs. | baseline, 6 week and 12 week reassessments | 
| Sleep Self-Efficacy | Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy. | baseline, 6 week and 12 week reassessments | 
| Actigraphy | Participants will wear an actigraph on their non-dominant wrist for 7 nights | baseline, 6 week and 12 week reassessments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Health, Older Adults