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

Sleep Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129045
• Other study ID #: BHSU
• Secondary ID: P20GM103443
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: Black Hills State University
• Contact: Ashley M Pfeiffer, DPT
• Phone: 16053815370
• Email: ashley.pfeiffer[@]bhsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Hygiene

Intervention

Behavioral:
• One-time educational video
Sleep hygiene educational tips provided through a video participants watch on their own.
• 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.

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 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
Primary	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
Primary	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	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
Secondary	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
Secondary	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