Trial Outcomes & Findings for Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults (NCT NCT05483920)
NCT ID: NCT05483920
Last Updated: 2024-03-15
Results Overview
Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 4-week follow up
Results posted on
2024-03-15
Participant Flow
Participant milestones
| Measure |
One-time Educational Video
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults
Baseline characteristics by cohort
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Sleep Hygiene Index
|
6.7 units on a scale
n=5 Participants
|
8.7 units on a scale
n=7 Participants
|
7.7 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4-week follow upPopulation: Change score average
Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index
|
1.6 units on a scale
Interval -1.0 to 7.0
|
2.5 units on a scale
Interval -1.0 to 10.0
|
PRIMARY outcome
Timeframe: Baseline and 4-week follow upPopulation: Average change scores
Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index
|
5.5 units on a scale
Interval -3.0 to 16.0
|
3.5 units on a scale
Interval -3.0 to 11.0
|
PRIMARY outcome
Timeframe: Baseline and 4-week follow upPopulation: Average change score
Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale
|
0.1 units on a scale
Interval -1.0 to 1.0
|
0.1 units on a scale
Interval -1.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline and 4-week follow upPopulation: average change score on ESS
Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale
|
1.3 units on a scale
Interval -4.0 to 8.0
|
2.3 units on a scale
Interval -1.0 to 8.0
|
PRIMARY outcome
Timeframe: Baseline, 4-week follow upSleep 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.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.
|
-1.34 percentage points of efficiency
Interval -8.5 to 2.5
|
-0.2 percentage points of efficiency
Interval -1.5 to 4.0
|
SECONDARY outcome
Timeframe: Baseline and 4-week follow upOutcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale
|
3.1 units on a scale
Interval -2.0 to 13.0
|
1.9 units on a scale
Interval -10.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline and 4-week follow upOutcome 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.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale
|
1.3 units on a scale
Interval -1.67 to 4.67
|
0.16 units on a scale
Interval -4.66 to 3.67
|
SECONDARY outcome
Timeframe: baseline and 4-week follow upBody 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.
Outcome measures
| Measure |
One-time Educational Video
n=15 Participants
A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video
|
One-time Educational Video Plus Automated Text Messaging
n=15 Participants
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
|
|---|---|---|
|
Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index
|
-0.001 kg/m^2 (kilograms/meters squared)
Interval -1.4 to 1.5
|
0.13 kg/m^2 (kilograms/meters squared)
Interval -1.4 to 1.1
|
Adverse Events
One-time Educational Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
One-time Educational Video Plus Automated Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place