An interventional study of One-time educational video and Educational video plus repeated education in Sleep Hygiene, sponsored by Black Hills State University. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Black Hills State University · Not applicable, Interventional, and Prevention
Among 41 studies in Sleep Hygiene with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Sleep Hygiene · United States.
Among the 41 studies in Sleep Hygiene with a site in United States, this one is the 13th largest by enrollment of the 39 interventional ones that give a count, is one of 8 that started in 2023, is one of 36 with no phase, and was the 33rd registered.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
Browse Sleep Hygiene studies →9 of the 41 studies in Sleep Hygiene with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Northern Arizona University · Sites in United States
University of Utah · Sites in United States
Farhaan S. Vahidy · Sites in United States
University of Utah · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Sleep Hygiene studies recruiting now, 4 (25%) set no upper age limit and 11 (69%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 1
First in 2004; this study’s year is marked. 8 started in 2023.
This study's enrollment of 125 is above the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Median enrollment 64 across the 39 interventional studies, 62 across the 2 observational. Of the 27 that completed or were terminated, 5 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 41 have an industry lead sponsor. The 10 most frequent:
Black Hills State University is the lead sponsor of 5 studies on the registry; none are open to participants now.
Black Hills State University has 2 studies filed under Sleep Hygiene — fewer than ten, so there is no comparison to draw.
4 of the studies in Sleep Hygiene with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07765849Northern Arizona UniversityOnline Sleep Education for College Student's Sleep Health and Executive Functioning | 2026-12 |
| NCT05943626University of UtahCircadian Intervention to Improve Cardiometabolic Health | 2026-12 |
| NCT07862348University of Alabama at BirminghamSleep Better, Live Better Study | 2027-07-31 |
| NCT05234125University of Illinois at ChicagoBetter Lifestyle Counseling for African American Women During Pregnancy | 2027-09-02 |
Among the 41 studies in Sleep Hygiene with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
One-time sleep hygiene education
Behavioral: One-time educational video
One-time sleep hygiene education plus repeated education through automated text messaging
Behavioral: Educational video plus repeated education
Control group with no intervention assigned
Sleep hygiene educational tips provided through a video participants watch on their own.
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.
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
Time frame: 6-weeks
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.
Time frame: 6-weeks
Change Score of Epworth Sleepiness Scale
Change 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.
Time frame: 6 week period
Change Score Total Sleep Time
The average total sleep time per night in minutes for each participant was recorded.
Time frame: 6 weeks
Change Score for Total Time Awake
The average total time awake per night in minutes for each participant was recorded.
Time frame: 6 weeks
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.
Time frame: 6-weeks
| Milestone | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Started | 40 | 42 | 43 |
| Completed | 39 | 41 | 39 |
| Not completed | 1 | 1 | 4 |
| Withdrew: Lost to follow-up | 1 | 1 | 4 |
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
| Score on a scale | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change Score of Pittsburgh Sleep Quality Index | 1 ± 3.01 | 1.12 ± 2.87 | -0.615 ± 3.02 |
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.
| score on a scale | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change Score of Sleep Hygiene Index | 2.41 ± 5.79 | 1.97 ± 5.29 | .64 ± 3.78 |
Change 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.
| score on a scale | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change Score of Epworth Sleepiness Scale | 1.6 ± 3.3 | 1.71 ± 2.1 | 0.39 ± 3.5 |
The average total sleep time per night in minutes for each participant was recorded.
| minutes per night | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change Score Total Sleep Time | -2.9 ± 52.9 | 8.24 ± 56.9 | -4.3 ± 45.4 |
The average total time awake per night in minutes for each participant was recorded.
| minutes per night | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change Score for Total Time Awake | -2.9 ± 22.8 | -1.7 ± 12.7 | 2.3 ± 13.2 |
Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.
| score on a scale | Group One, Video | Group Two, Video Plus Texts | Group Three, |
|---|---|---|---|
| Change on the Perceived Stress Scale | -0.11 ± 3.85 | 1.71 ± 4.51 | 0.23 ± 3.17 |
Collected over From enrollment until end of follow-up, 6 week time period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group One, Video | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Group Two, Video Plus Texts | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Group Three, | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Continuous(years) | Group One, Video | Group Two, Video Plus Texts | Group Three, | Total |
|---|---|---|---|---|
| Mean | 66.5 ± 8.2 | 66.7 ± 6.1 | 66.3 ± 7.4 | 66.5 ± 7.2 |
| Sex: Female, Male(Participants) | Group One, Video | Group Two, Video Plus Texts | Group Three, | Total |
|---|---|---|---|---|
| Female | 23 | 31 | 24 | 78 |
| Male | 16 | 10 | 15 | 41 |
| Race (NIH/OMB)(Participants) | Group One, Video | Group Two, Video Plus Texts | Group Three, | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 3 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 36 | 40 | 39 | 115 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group One, Video | Group Two, Video Plus Texts | Group Three, | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 39 | 41 | 39 | 119 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Readiness to change sleep behavior 0-10 visual analog scale(units on a scale) | Group One, Video | Group Two, Video Plus Texts | Group Three, | Total |
|---|---|---|---|---|
| Mean | 5.97 ± 3.30 | 7.02 ± 3.00 | 6.43 ± 2.89 | 6.49 ± 3.07 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — all IPD that underlie results in a publication
Ran from Oct 2023 to primary completion in Aug 2025, 21 months.
Results were first posted in Nov 2025, 3 months after primary completion.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 21 months is above that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Black Hills State University