NCT05483920

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

Completed NA Results posted Last updated 15 March 2024

What this trial tests

NA trial testing One-time educational video in Sleep Habit, Good in 30 participants. Completed in 1 August 2023.

Timeline

1 January 2023

Primary endpoint
30 May 2023

1 August 2023

Quick facts

Lead sponsor	Black Hills State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	1 January 2023
Primary completion	30 May 2023
Estimated completion	1 August 2023
Sites	1 location across United States

Drugs / interventions tested

• One-time educational video
• One-time educational video plus automated text messaging

Conditions studied

• Sleep Habit, Good — all drugs for Sleep Habit, Good →
• Sleep Hygiene — all drugs for Sleep Hygiene →
• Health Behavior — all drugs for Health Behavior →

Sponsor

Black Hills State University

Who can join

Adults 50 to 80, any sex, with Sleep Habit, Good or Sleep Hygiene. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index Primary · Baseline and 4-week follow up

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

Group	Value	95% CI
One-time Educational Video	1.6	-1 – 7
One-time Educational Video Plus Automated Text Messaging	2.5	-1 – 10

Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index Primary · Baseline and 4-week follow up

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

Group	Value	95% CI
One-time Educational Video	5.5	-3 – 16
One-time Educational Video Plus Automated Text Messaging	3.5	-3 – 11

Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale Primary · Baseline and 4-week follow up

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

Group	Value	95% CI
One-time Educational Video	0.1	-1 – 1
One-time Educational Video Plus Automated Text Messaging	0.1	-1 – 1

Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale Primary · Baseline and 4-week follow up

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

Group	Value	95% CI
One-time Educational Video	1.3	-4 – 8
One-time Educational Video Plus Automated Text Messaging	2.3	-1 – 8

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

Group	Value	95% CI
One-time Educational Video	-1.34	-8.5 – 2.5
One-time Educational Video Plus Automated Text Messaging	-0.2	-1.5 – 4

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

Group	Value	95% CI
One-time Educational Video	3.1	-2 – 13
One-time Educational Video Plus Automated Text Messaging	1.9	-10 – 9

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

Group	Value	95% CI
One-time Educational Video	1.3	-1.67 – 4.67
One-time Educational Video Plus Automated Text Messaging	0.16	-4.66 – 3.67

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

Group	Value	95% CI
One-time Educational Video	-0.001	-1.4 – 1.5
One-time Educational Video Plus Automated Text Messaging	0.13	-1.4 – 1.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.