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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Hygiene
• Intervention / Treatment: Behavioral: One-time educational video; Behavioral: Educational video plus repeated education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley M Pfeiffer, DPT; Phone Number: 16053815370; Email: ashley.pfeiffer@bhsu.edu
• Study Contact Backup: Name: Cate Caldwell; Phone Number: (605)642-6371; Email: Cate.Caldwell@bhsu.edu

Study Locations

• United States
  • South Dakota
    • Spearfish, South Dakota, United States, 57799
      • Recruiting
      • Black Hills State University
      • Contact: Ashley M Pfeiffer; Phone Number: 605-381-5370; Email: ashley.pfeiffer@bhsu.edu
      • Contact: Email: maas5522@gmail.com
      • Principal Investigator: Ashley M Pfeiffer
      • Sub-Investigator: Craig Triplett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group One, Video; One-time sleep hygiene education	Behavioral: One-time educational video; Sleep hygiene educational tips provided through a video participants watch on their own.
Experimental: Group Two, Video Plus Texts; One-time sleep hygiene education plus repeated education through automated text messaging	Behavioral: Educational video plus repeated education; 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.
No Intervention: Group Three,; Control group with no intervention assigned

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all IPD that underlie results in a publication

Drug and device information, study documents

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