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

NCT05483920 | Completed Results

• 2 other identifiers: BlackHillsSTP20GM103443
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Habit, Good; Sleep Hygiene; Health Behavior

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

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

  Baseline and 4-week follow up

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

  Baseline and 4-week follow up

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

  baseline and 4-week follow up

Study Arms (2)

One-time educational video

EXPERIMENTAL

A one-time educational video on best practices for good sleep hygiene

Behavioral: One-time educational video

One-time educational video plus automated text messaging

EXPERIMENTAL

A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.

Behavioral: One-time educational video plus automated text messaging

Interventions

One-time educational video BEHAVIORAL

One-time educational video

One-time educational video

One-time educational video plus automated text messaging BEHAVIORAL

Educational video plus automated text messaging

One-time educational video plus automated text messaging

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult between the ages of 50 and 80 will be recruited for the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Black Hills State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Black Hills State University

Spearfish, South Dakota, 57799, United States

Location

MeSH Terms

Conditions

Sleep Hygiene; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Limitations of the study include a small sample size, and minimal heterogeneity of gender, and race. We were limited to one geographical region.

Results Point of Contact

• Title: Dr. Ashley Pfeiffer
• Organization: Black Hills State University

ashley.pfeiffer@bhsu.edu

(605) 381-5370

Study Officials

• Ashley M Pfeiffer

  Black Hills State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be two arms of the study including intervention and a control group.

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: January 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: August 1, 2023
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)