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OpenTrials
Completed

NCT Number: NCT06129045

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.

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Key information

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

One-time educational video

Behavioral

Sleep hygiene educational tips provided through a video participants watch on their own.

Educational video plus repeated education

Behavioral

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.

Primary outcomes

  1. Change Score of Pittsburgh Sleep Quality Index

    Time frame: 6-weeks

    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

  2. Change Score of Sleep Hygiene Index

    Time frame: 6-weeks

    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.

  3. Change Score of Epworth Sleepiness Scale

    Time frame: 6 week period

    Change Score From Baseline to 6-week Follow up on the Epworth Sleepiness Scale. Outcome measure for daytime sleepiness. Score ranges 0-24 with higher score equaling worst daytime sleepiness.

  4. Change Score Total Sleep Time

    Time frame: 6 weeks

    The average total sleep time per night in minutes for each participant was recorded.

  5. Change Score for Total Time Awake

    Time frame: 6 weeks

    The average total time awake per night in minutes for each participant was recorded.

Secondary outcomes

  1. Change on the Perceived Stress Scale

    Time frame: 6-weeks

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

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
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Nov 24, 2025

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.

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