Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80

Study Overview
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Brief Summary
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This will be a study looking at trying to change older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.

Detailed Description
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Older adults ages 50-80 will be recruited and placed into one of three groups. Group One will watch a one-time educational video on sleep hygiene, Group Two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video, and Group Three will be a control group with no intervention. The participants in Groups One and Two will receive the education after two weeks of data tracking on a Fitbit device. They then will have four additional weeks of tracking. At the end of the study time of six weeks, all participants will return for follow-up testing. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep.

Official Title
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Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80

Conditions
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Sleep Hygiene

Intervention / Treatment
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* Behavioral: One-time educational video
* Behavioral: Educational video plus repeated education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: own a smartphone with the capability of receiving text messages. Exclusion Criteria: an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea inability to wear the device on their wrist

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm study: No intervention, video only, video plus text messaging
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group One, Video<br>One-time sleep hygiene education | Behavioral: One-time educational video<br>* Sleep hygiene educational tips provided through a video participants watch on their own.<br>|
| Experimental: Group Two, Video Plus Texts<br>One-time sleep hygiene education plus repeated education through automated text messaging | Behavioral: Educational video plus repeated education<br>* Sleep hygiene educational tips are provided first through a video participants watch on their own and then tips are repeated through daily automated text messaging for an additional 4 weeks.<br>|
| No Intervention: Group Three,<br>Control group with no intervention assigned | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores of Ru-Sated Sleep Composite for overall sleep health using six health domains. | Each domain is dichotomized using cut-off points with 0 = poor sleep health and 1 = good sleep health. The domains are summed to create the composite sleep health score ranging from 0 - 6 with a higher score indicating better sleep health. Collected through FitBit and subjective questions. Regularity: Standard deviation of sleep midpoint, which is calculated as [sleep onset +(wake time - sleep onset/2)]. Cut-off is <60 minutes. Satisfaction. Definition: Rate restedness upon awakening Satisfaction will be the average restedness score. Cut-off is an average of ≥3. Alertness: Definition: Epworth Sleepiness Scale which consists of 8 items of various activities answered. Cut off score is ≤10. Timing: Definition: Average sleep midpoint. Cut-off is 2am to 4am. Efficiency: Definition: Average total minutes of sleep divided by time in bed multiplied by 100. Cut-off score is >85% Duration: Definition: Average total minutes of sleep. Cut-off is 6-8 hours | 6-weeks | 
| Change score of Pittsburgh Sleep Quality Index | Change Score From Baseline to 6-week Follow up on the Pittsburgh Sleep Quality Index. Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality | 6-weeks | 
| Change score of Sleep Hygiene Index | Change Score From Baseline to 6-week Follow up on the Sleep Hygiene Index. Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene. | 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Score on the Numeric Pain Rating Scale | Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels. | 6-weeks | 
| Change on the Perceived Stress Scale | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. | 6-weeks | 
| Change Scores for Participant's Body Mass Index | Body mass index is measured by body weight [kg]/ height [m]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight. | 6-weeks |