Back to resultsSleep Health Enhancement in Older Adults to Address Frailty
Primary Purpose
Frailty
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sleep Health Enhancement Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring Sleep Health, Older Adults
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sleep Health Enhancement Intervention
Wait-List Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
6-item Acceptability Scale
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
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
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.
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.
Ru_SATED sleep health composite
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires
Secondary Outcome Measures
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.
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.
Dysfunctional Beliefs About Sleep
This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
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.
Actigraphy
Participants will wear an actigraph on their non-dominant wrist for 7 nights
Full Information
NCT ID
NCT05968820
First Posted
July 18, 2023
Last Updated
July 28, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05968820
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Sleep Health, Older Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep Health Enhancement Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-List Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health Enhancement Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-item Acceptability Scale
Description
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
Time Frame
6 week
Title
semi-standardized qualitative interview
Description
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
Time Frame
6 week
Title
Tilburg Frailty Indicator
Description
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.
Time Frame
baseline, 6 week and 12 week reassessments
Title
WHOQOL-BREF
Description
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.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Ru_SATED sleep health composite
Description
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires
Time Frame
baseline, 6 week and 12 week reassessments
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of >5 indicates poor sleep quality.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Epworth Sleepiness Scale
Description
Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Dysfunctional Beliefs About Sleep
Description
This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Sleep Self-Efficacy
Description
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.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Actigraphy
Description
Participants will wear an actigraph on their non-dominant wrist for 7 nights
Time Frame
baseline, 6 week and 12 week reassessments
Other Pre-specified Outcome Measures:
Title
Timed Up and Go
Description
Timed Up and Go measures functional mobility and consists of sitting in a chair, standing up, walking 3-m, turning around, returning to the chair, and sitting down. The outcome is the time in seconds it takes to complete the task.
Time Frame
baseline, 6 week and 12 week reassessments
Title
15 ft walk test
Description
The test is performed in a hallway or open space, and the time it takes to walk 15 ft is noted in seconds.
Time Frame
baseline, 6 week and 12 week reassessments
Title
6-Minute Walk Test (6MWT)
Description
The test is performed in a hallway or open space with two cones marking the turn-around points. The participant walks between the two cones for six minutes. Distance is measured by number of laps completed.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Grip strength of the dominant and nondominant hand
Description
Grip strength of the dominant and nondominant hand will be assessed using a dynamometer with the participant seated, elbow flexed to 90 degrees, and arm by their side. The participant will perform one practice submaximal effort for acclimation followed by one maximal effort squeeze.
Time Frame
baseline, 6 week and 12 week reassessments
Title
The Continuous Performance Test (CPT)
Description
The Continuous Performance Test (CPT) requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except "X." The participants' scores will be determined by their scores in detectability (e.g., difficulty differentiating targets from non-targets), error type (e.g., omissions, commissions, perseverations) and reaction time statistics.
Time Frame
baseline, 6 week and 12 week reassessments
Title
The Stroop Test
Description
The Stroop Test requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color). Each participant is given a list of X's printed in colored ink and a list of words printed in colored ink. The participant is instructed to name the color of the ink. They are given 45 seconds to name as many colors as they can. The reported outcome measure of this test is an interference score that is the difference between the two conditions while normalizing for number of x's using the following formulae: x-words/x.
Time Frame
baseline, 6 week and 12 week reassessments
Title
Cognitive Failures Questionnaire (CFQ)
Description
Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
Time Frame
baseline, 6 week and 12 week reassessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Siengsukon, PhD
Phone
913-588-6913
Email
csiengsukon@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eryen Nelson, MPH
Phone
913-945-7349
Email
enelson5@kumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Sleep Health Enhancement in Older Adults to Address Frailty
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