Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults

This will be a study looking at trying to change community-dwelling 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.

Study Overview

• Status: Completed
• Conditions: Health Behavior; Sleep Hygiene; Sleep Habit, Good
• Intervention / Treatment: Behavioral: One-time educational video; Behavioral: One-time educational video plus automated text messaging

Detailed Description

Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. 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. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Spearfish, South Dakota, United States, 57799
      • Black Hills State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Any adult between the ages of 50 and 80 will be recruited for the study

Exclusion Criteria:

• Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-time educational video; A one-time educational video on best practices for good sleep hygiene	Behavioral: One-time educational video; One-time educational video
Experimental: One-time educational video plus automated text messaging; A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.	Behavioral: One-time educational video plus automated text messaging; Educational video plus automated text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Score From Baseline to 4-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	Baseline and 4-week follow up
Change Score From Baseline to 4-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.	Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale	Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.	Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale	Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.	Baseline and 4-week follow up
Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.	Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score.	Baseline, 4-week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Score From Baseline to 4-week Follow up 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.	Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale	Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10.	Baseline and 4-week follow up
Change Scores From Baseline to 4-week Follow up 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.	baseline and 4-week follow up

Collaborators and Investigators

• Sponsor: Black Hills State University
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Ashley M Pfeiffer, Black Hills State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BlackHillsST; P20GM103443 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No