Sleep HygieneNCT06129045

Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80

A study testing One-time educational video and Educational video plus repeated education in people with Sleep Hygiene, run by Black Hills State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Hygiene
What is being tested?: One-time educational video and Educational video plus repeated education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2023to 1 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

own a smartphone with the capability of receiving text messages.

Who cannot join

an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
inability to wear the device on their wrist

Trial locations and contacts

1 site in 1 country.

United States1 site

Black Hills State University
Spearfish, South Dakota, 57799

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Sleep Hygiene
Being tested: One-time educational video, Educational video plus repeated education
Keywords: Behavior Change, Older adults, sleep hygiene
Medical subject headings: Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

One-time educational videoBehavioural
Sleep hygiene educational tips provided through a video participants watch on their own.
Educational video plus repeated educationBehavioural
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.

Study groups in NCT06129045
Study group	Role	What they receive
Group One, Video	Experimental	One-time sleep hygiene education Receives: Behavioral: One-time educational video
Group Two, Video Plus Texts	Experimental	One-time sleep hygiene education plus repeated education through automated text messaging Receives: Behavioral: Educational video plus repeated education
Group Three,	No intervention	Control group with no intervention assigned

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 6 week period
Change Score Total Sleep Time
The average total sleep time per night in minutes for each participant was recorded.
Measured: 6 weeks
Change Score for Total Time Awake
The average total time awake per night in minutes for each participant was recorded.
Measured: 6 weeks

Secondary outcomes (1)

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.
Measured: 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 20231 Aug 2025

First posted13 Nov 2023
Study start4 Oct 2023
Primary completion1 Aug 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep HygieneStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three arm study: No intervention, video only, video plus text messaging
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06129045
Sponsor's protocol ID: BHSU
Other IDs: P20GM103443
Status last verified: Nov 2025
First submitted: 8 Nov 2023
Last updated: 24 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: all IPD that underlie results in a publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Hygiene trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80
ClinicalTrials.gov ID: NCT06129045
Acronym / sponsor ID: BHSU
Conditions: Sleep Hygiene
Keywords: Behavior Change, Older adults, sleep hygiene
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Black Hills State UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 4 Oct 2023 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 13 Nov 2023 (actual)
Results: Posted 24 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Three arm study: No intervention, video only, video plus text messaging

Arm	Type	Receives
Group One, Video	Experimental	Behavioral: One-time educational videoOne-time sleep hygiene education
Group Two, Video Plus Texts	Experimental	Behavioral: Educational video plus repeated educationOne-time sleep hygiene education plus repeated education through automated text messaging
Group Three,	No intervention	–Control group with no intervention assigned

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

own a smartphone with the capability of receiving text messages.

Key exclusion criteria (2 listed)

an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
inability to wear the device on their wrist

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
One-time educational videoSleep hygiene educational tips provided through a video participants watch on their own.	Behavioural	Group One, Video
Educational video plus repeated educationSleep 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.	Behavioural	Group Two, Video Plus Texts

Primary outcome

Change Score of Pittsburgh Sleep Quality Index
Time frame: 6-weeks
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
Change Score of Sleep Hygiene Index
Time frame: 6-weeks
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.
Change Score of Epworth Sleepiness Scale
Time frame: 6 week period
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.
Change Score Total Sleep Time
Time frame: 6 weeks
The average total sleep time per night in minutes for each participant was recorded.
Change Score for Total Time Awake
Time frame: 6 weeks
The average total time awake per night in minutes for each participant was recorded.

1 secondary outcome

Change on the Perceived Stress Scale
Time frame: 6-weeks

Results and safety

Results posted to the registry on 24 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group One, Video	40	39
Group Two, Video Plus Texts	42	41
Group Three,	43	39

Primary outcome: Change Score of Pittsburgh Sleep Quality Index

Time frame: 6-weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	Group One, Video n = 38	Group Two, Video Plus Texts n = 41	Group Three, n = 39
Value	1 (3.01)	1.12 (2.87)	-0.615 (3.02)

Population analysed: One person did not complete the PSQI on follow-up in the video only group due to technology error.

Primary outcome: Change Score of Sleep Hygiene Index

Time frame: 6-weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Group One, Video n = 39	Group Two, Video Plus Texts n = 41	Group Three, n = 39
Value	2.41 (5.79)	1.97 (5.29)	.64 (3.78)

Primary outcome: Change Score of Epworth Sleepiness Scale

Time frame: 6 week period. Mean (Standard Deviation). Unit: score on a scale

Measure	Group One, Video n = 39	Group Two, Video Plus Texts n = 41	Group Three, n = 39
Value	1.6 (3.3)	1.71 (2.1)	0.39 (3.5)

Primary outcome: Change Score Total Sleep Time

Time frame: 6 weeks. Mean (Standard Deviation). Unit: minutes per night

Measure	Group One, Video n = 39	Group Two, Video Plus Texts n = 41	Group Three, n = 39
Value	-2.9 (52.9)	8.24 (56.9)	-4.3 (45.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, 6 week time period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group One, Video	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Group Two, Video Plus Texts	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Group Three,	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. all IPD that underlie results in a publication

Related trials for Sleep Hygiene

Not yet recruiting
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV
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Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashley M Pfeiffer, DPT principal investigator

Black Hills State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing One-time educational video and Educational video plus repeated education in people with Sleep Hygiene, run by Black Hills State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Score of Pittsburgh Sleep Quality Index (time frame: 6-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.