Trial Outcomes & Findings for Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80 (NCT NCT06129045)
NCT ID: NCT06129045
Last Updated: 2025-11-24
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
6-weeks
Results posted on
2025-11-24
Participant Flow
We recruited 125 participants who completed the informed consent and intial evaluation. Six participants dropped out due to personal reasons leaving 119 participants that were able to see the study through to the conclusion. Funding ran out prior to being able to recruit any additional participants.
Participant milestones
| Measure |
Group One, Video
One-time sleep hygiene education
|
Group Two, Video Plus Texts
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
Control group with no intervention assigned
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
43
|
|
Overall Study
COMPLETED
|
39
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Group One, Video
One-time sleep hygiene education
|
Group Two, Video Plus Texts
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
Control group with no intervention assigned
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
4
|
Baseline Characteristics
The average score on the readiness to change 0-10 scale is documented below for each intervention group.
Baseline characteristics by cohort
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 8.2 • n=45 Participants
|
66.7 years
STANDARD_DEVIATION 6.1 • n=12929 Participants
|
66.3 years
STANDARD_DEVIATION 7.4 • n=6349 Participants
|
66.5 years
STANDARD_DEVIATION 7.2 • n=4548 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=45 Participants
|
31 Participants
n=12929 Participants
|
24 Participants
n=6349 Participants
|
78 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
15 Participants
n=6349 Participants
|
41 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=45 Participants
|
40 Participants
n=12929 Participants
|
39 Participants
n=6349 Participants
|
115 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=45 Participants
|
41 Participants
n=12929 Participants
|
39 Participants
n=6349 Participants
|
119 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Readiness to change sleep behavior 0-10 visual analog scale
|
5.97 units on a scale
STANDARD_DEVIATION 3.30 • n=45 Participants • The average score on the readiness to change 0-10 scale is documented below for each intervention group.
|
7.02 units on a scale
STANDARD_DEVIATION 3.00 • n=12929 Participants • The average score on the readiness to change 0-10 scale is documented below for each intervention group.
|
6.43 units on a scale
STANDARD_DEVIATION 2.89 • n=6349 Participants • The average score on the readiness to change 0-10 scale is documented below for each intervention group.
|
6.49 units on a scale
STANDARD_DEVIATION 3.07 • n=4548 Participants • The average score on the readiness to change 0-10 scale is documented below for each intervention group.
|
PRIMARY outcome
Timeframe: 6-weeksPopulation: One person did not complete the PSQI on follow-up in the video only group due to technology error.
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
Outcome measures
| Measure |
Group One, Video
n=38 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change Score of Pittsburgh Sleep Quality Index
|
1 Score on a scale
Standard Deviation 3.01
|
1.12 Score on a scale
Standard Deviation 2.87
|
-0.615 Score on a scale
Standard Deviation 3.02
|
PRIMARY outcome
Timeframe: 6-weeksChange 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.
Outcome measures
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change Score of Sleep Hygiene Index
|
2.41 score on a scale
Standard Deviation 5.79
|
1.97 score on a scale
Standard Deviation 5.29
|
.64 score on a scale
Standard Deviation 3.78
|
PRIMARY outcome
Timeframe: 6 week periodChange 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.
Outcome measures
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change Score of Epworth Sleepiness Scale
|
1.6 score on a scale
Standard Deviation 3.3
|
1.71 score on a scale
Standard Deviation 2.1
|
0.39 score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 6 weeksThe average total sleep time per night in minutes for each participant was recorded.
Outcome measures
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change Score Total Sleep Time
|
-2.9 minutes per night
Standard Deviation 52.9
|
8.24 minutes per night
Standard Deviation 56.9
|
-4.3 minutes per night
Standard Deviation 45.4
|
PRIMARY outcome
Timeframe: 6 weeksThe average total time awake per night in minutes for each participant was recorded.
Outcome measures
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change Score for Total Time Awake
|
-2.9 minutes per night
Standard Deviation 22.8
|
-1.7 minutes per night
Standard Deviation 12.7
|
2.3 minutes per night
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 6-weeksOutcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.
Outcome measures
| Measure |
Group One, Video
n=39 Participants
One-time sleep hygiene education
|
Group Two, Video Plus Texts
n=41 Participants
One-time sleep hygiene education plus repeated education through automated text messaging
|
Group Three,
n=39 Participants
Control group with no intervention assigned
|
|---|---|---|---|
|
Change on the Perceived Stress Scale
|
-0.11 score on a scale
Standard Deviation 3.85
|
1.71 score on a scale
Standard Deviation 4.51
|
0.23 score on a scale
Standard Deviation 3.17
|
Adverse Events
Group One, Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Two, Video Plus Texts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Three,
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