Skip to main content
OpenTrials
Completed

NCT Number: NCT05483920

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Habit, Good Behavior Health Behavior Sleep Hygiene

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Black Hills State University

Spearfish, South Dakota, 57799, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One-time educational video

Behavioral

One-time educational video

One-time educational video plus automated text messaging

Behavioral

Educational video plus automated text messaging

Primary outcomes

  1. Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index

    Time frame: Baseline and 4-week follow up

    Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality

  2. Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index

    Time frame: Baseline and 4-week follow up

    Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.

  3. Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale

    Time frame: Baseline and 4-week follow up

    Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.

  4. Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale

    Time frame: Baseline and 4-week follow up

    Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.

  5. Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.

    Time frame: Baseline, 4-week follow up

    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.

Secondary outcomes

  1. Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale

    Time frame: Baseline and 4-week follow up

    Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.

  2. Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale

    Time frame: Baseline and 4-week follow up

    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.

  3. Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index

    Time frame: baseline and 4-week follow up

    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.

Sponsors and collaborators

Lead sponsor

Black Hills State University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.