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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483920
• Other study ID #: BlackHillsST
• Secondary ID: P20GM103443
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2024
• Source: Black Hills State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Sleep Hygiene

Intervention

Behavioral:
• One-time educational video
One-time educational video
• One-time educational video plus automated text messaging
Educational video plus automated text messaging

Locations

Country	Name	City	State
United States	Black Hills State University	Spearfish	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Black Hills State University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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