Sleep Habit, GoodNCT05483920
Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults
A study testing One-time educational video and One-time educational video plus automated text messaging in people with Sleep Habit, Good and Sleep Hygiene, run by Black Hills State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Habit, Good, Sleep Hygiene, Health Behavior
- What is being tested?
- One-time educational video and One-time educational video plus automated text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Aug 2023
- 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
- Any adult between the ages of 50 and 80 will be recruited for the study
Who cannot join
- Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Black Hills State University
Spearfish, South Dakota, 57799
About this study
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.
Read the detailed description
Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. 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. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.
- Conditions
- Sleep Habit, Good, Sleep Hygiene, Health Behavior
- Being tested
- One-time educational video, One-time educational video plus automated text messaging
- Medical subject headings
- Sleep Hygiene, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-time educational videoBehavioural
One-time educational video
One-time educational video plus automated text messagingBehavioural
Educational video plus automated text messaging
| Study group | Role | What they receive |
|---|---|---|
| One-time educational video | Experimental | A one-time educational video on best practices for good sleep hygiene Receives: Behavioral: One-time educational video |
| One-time educational video plus automated text messaging | Experimental | A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit. Receives: Behavioral: One-time educational video plus automated text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Score From Baseline to 4-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: Baseline and 4-week follow up
Change Score From Baseline to 4-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: Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale
Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.
Measured: Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale
Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.
Measured: Baseline and 4-week follow up
Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.
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.
Measured: Baseline, 4-week follow up
Secondary outcomes (3)
Change Score From Baseline to 4-week Follow up 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: Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale
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.
Measured: Baseline and 4-week follow up
Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index
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.
Measured: baseline and 4-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jan 2023
- Primary completion30 May 2023
- Study completion1 Aug 2023
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 Habit, GoodStudies 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
- There will be two arms of the study including intervention and a control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Black Hills State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Ashley Pfeiffer, Black Hills State University
- Investigators
- Ashley M Pfeiffer, Principal investigator, Black Hills State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483920
- Sponsor's protocol ID
- BlackHillsST
- Other IDs
- P20GM103443
- Status last verified
- Feb 2024
- First submitted
- 29 Jul 2022
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05483920
- Acronym / sponsor ID
- BlackHillsST
- Conditions
- Sleep Habit, Good, Sleep Hygiene, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Black Hills State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. 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. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two arms of the study including intervention and a control group.
| Arm | Type | Receives |
|---|---|---|
| One-time educational video | Experimental | Behavioral: One-time educational videoA one-time educational video on best practices for good sleep hygiene |
| One-time educational video plus automated text messaging | Experimental | Behavioral: One-time educational video plus automated text messagingA one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult between the ages of 50 and 80 will be recruited for the study
Key exclusion criteria (1 listed)
- Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking 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 videoOne-time educational video | Behavioural | One-time educational video |
| One-time educational video plus automated text messagingEducational video plus automated text messaging | Behavioural | One-time educational video plus automated text messaging |
Primary outcome
Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index
Time frame: Baseline and 4-week follow up
Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality
Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index
Time frame: Baseline and 4-week follow up
Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.
Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale
Time frame: Baseline and 4-week follow up
Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.
Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale
Time frame: Baseline and 4-week follow up
Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.
Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.
Time frame: 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.
3 secondary outcomes
Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale
Time frame: Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale
Time frame: Baseline and 4-week follow up
Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index
Time frame: baseline and 4-week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sleep Habit, Good
Not yet recruiting
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Recruiting
Sleep Better, Live Better Study
Sleep Hygiene, Sleep Duration
Recruiting
Online Sleep Education for College Student's Sleep Health and Executive Functioning
Sleep, Executive Functioning
Not yet recruiting
A Theory-based Sleep Hygiene Education for Insomnia Disorder
Insomnia, Adults
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 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 One-time educational video plus automated text messaging in people with Sleep Habit, Good and 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 1 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 15 Mar 2024. 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 15 Mar 2024). 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 From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index (time frame: Baseline and 4-week follow up). 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?
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 15 Mar 2024.