Sleep HygieneNCT04849572
Sleep Well Live Well (SWELL) Pilot Project
A study testing Sleep Education and Delayed Sleep Education in people with Sleep Hygiene, run by West Virginia University at 1 site in United States.
Trial summary
This will be a 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks. Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Hygiene
- What is being tested?
- Sleep Education and Delayed Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 6 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reside in Harrison County of West Virginia
- Ability to read and understand English
- Ability to provide informed consent
Who cannot join
- Inability to read and understand English
- Inability or unwillingness to provide informed consent
- Presence of sleep apnea
- Depression
- Severe insomnia
- Using prescription sleeping medication or narcotics
- Acute illness including stroke, heart attack, heart failure or pneumonia with or without COVID-19 infection requiring hospital admission within the last 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26508
About this study
This will be a 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks. Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention).
Read the detailed description
The primary aim of this study is to assess if sleep hygiene education increases sleep duration and sleep quality in an Appalachian community. To accomplish these aims, the investigators will assess changes in sleep duration by the Oura ring and the PSQI and Epworth Sleepiness Scale (ESS). Secondary aims are to determine whether sleep hygiene education decreases heart rate variability measured by the Oura ring and improves alertness as assessed by psychomotor vigilance testing (PVT). Potential participants will be recruited via brochures, poster displays and on-line media to participate in the study. Those eligible will be asked to complete a questionnaire to record baseline demographics. The data collected will be demographic information, presence of chronic medical conditions, validated sleep questionnaires, PVT results and Oura ring (https://ouraring.com/) output. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start. Each subject (in both groups) will have pre- and post-intervention data in this study. Therefore, the "real" control in this study is the subject himself/herself (after taking the difference), which will minimize any confounding factors/effect; If the investigators assume that more education duration will result in more benefit, the investigators have a chance to assess a dose-response curve ("dosage" = education duration). The investigators will fit a mixed-effects model with duration as a fixed effect, adjusting for potential confounding variables if any.
- Conditions
- Sleep Hygiene
- Being tested
- Sleep Education, Delayed Sleep Education
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep EducationBehavioural
- Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks.
- Week 3: 50 participants (Arm 1) will watch a 10 to 20 minute sleep hygiene video followed by a post-test questionnaire to confirm participation and understanding.
- Week 5: Arm 1 will again view the educational video at week 5
- Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling).
- Week 9: Arm 1 will continue re-education
- Week 11: Arm 1 continues education
- Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.
Delayed Sleep EducationBehavioural
- Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks.
- Week 3: 50 participants (Arm 2) will be controls with no education.
- Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling).
- Week 9: Arm 2 will join in for video education along with post-test
- Week 11: Arm 2 will undergo reeducation with post-test for 20 mins
- Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education | Active comparator | Also referred to as Arm 1. Arm 1 receives sleep education initially. Receives: Behavioral: Sleep Education |
| Delayed Sleep Education | Active comparator | Also referred to Arm 2. Arm 2 receives no initial sleep education. Receives: Behavioral: Delayed Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total sleep time
A 20 minute or more difference in total sleep time between Arm 1 (sleep education) and Arm 2 (no initial sleep education).
Measured: 6 Weeks
Change in the ESS in Arm 1 (≥2 points)
The Epworth Sleepiness Scale (ESS) is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the subjects rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the subjects finish the test, add up the values of the responses. The subjects total score is based on a scale of 0 to 24. The scale estimates whether the subjects are experiencing excessive sleepiness that possibly requires medical attention.
Measured: 6 Weeks
Change in PSQI at 6 weeks in Arm 1 (≥3 points)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "O" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "O" indicating no difficulty and "21 " indicating severe difficulties in all areas.
Measured: 6 Weeks
Secondary outcomes (3)
Change in total sleep time
Change in total sleep time variability (> 1 hour) in both groups. Changes in sleep duration will be assessed by the Oura ring, a novel sleep monitoring device.
Measured: 6 weeks after sleep education
Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups
The primary outcome measures of PVT performance, lapses, are defined as reaction times exceeding 500 msec or failure to react. The PVT lapses are believed to represent perceptual, processing, or executive failures in the central nervous system (CNS).
Measured: 6 weeks after sleep education
Change in heart rate variability in both groups
Measured by the Oura Ring
Measured: 6 weeks after sleep education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start14 Sep 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- This is a permuted block randomization study to assess the efficacy of the new intervention and the primary outcome variable is the sleep time. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849572
- Sponsor's protocol ID
- 2103262999
- Status last verified
- Aug 2023
- First submitted
- 13 Apr 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharma S, Stansbury R, Ramadan J, Rojas E, Finomore V, Pham C, Quan SF, Wen S. Sleep well and live well: Impact of sleep hygiene intervention on sleep duration in a rural community: A randomized controlled trial (THE SWELL STUDY). J Rural Health. 2025 Jan;41(1):e70002. doi: 10.1111/jrh.70002.
PubMed 39930329
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Well Live Well (SWELL) Pilot Project
- ClinicalTrials.gov ID
- NCT04849572
- Acronym / sponsor ID
- 2103262999
- Conditions
- Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
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 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks. Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention).
Detailed description
The primary aim of this study is to assess if sleep hygiene education increases sleep duration and sleep quality in an Appalachian community. To accomplish these aims, the investigators will assess changes in sleep duration by the Oura ring and the PSQI and Epworth Sleepiness Scale (ESS). Secondary aims are to determine whether sleep hygiene education decreases heart rate variability measured by the Oura ring and improves alertness as assessed by psychomotor vigilance testing (PVT). Potential participants will be recruited via brochures, poster displays and on-line media to participate in the study. Those eligible will be asked to complete a questionnaire to record baseline demographics. The data collected will be demographic information, presence of chronic medical conditions, validated sleep questionnaires, PVT results and Oura ring (https://ouraring.com/) output. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start. Each subject (in both groups) will have pre- and post-intervention data in this study. Therefore, the "real" control in this study is the subject himself/herself (after taking the difference), which will minimize any confounding factors/effect; If the investigators assume that more education duration will result in more benefit, the investigators have a chance to assess a dose-response curve ("dosage" = education duration). The investigators will fit a mixed-effects model with duration as a fixed effect, adjusting for potential confounding variables if any.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a permuted block randomization study to assess the efficacy of the new intervention and the primary outcome variable is the sleep time. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start.
| Arm | Type | Receives |
|---|---|---|
| Sleep Education | Active comparator | Behavioral: Sleep EducationAlso referred to as Arm 1. Arm 1 receives sleep education initially. |
| Delayed Sleep Education | Active comparator | Behavioral: Delayed Sleep EducationAlso referred to Arm 2. Arm 2 receives no initial sleep education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reside in Harrison County of West Virginia
- Ability to read and understand English
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Inability to read and understand English
- Inability or unwillingness to provide informed consent
- Presence of sleep apnea
- Depression
- Severe insomnia
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 |
|---|---|---|
| Sleep Education* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 1) will watch a 10 to 20 minute sleep hygiene video followed by a post-test questionnaire to confirm participation and understanding. * Week 5: Arm 1 will again view the educational video at week 5 * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 1 will continue re-education * Week 11: Arm 1 continues education * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups. | Behavioural | Sleep Education |
| Delayed Sleep Education* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 2) will be controls with no education. * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 2 will join in for video education along with post-test * Week 11: Arm 2 will undergo reeducation with post-test for 20 mins * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups. | Behavioural | Delayed Sleep Education |
Primary outcome
Difference in total sleep time
Time frame: 6 Weeks
A 20 minute or more difference in total sleep time between Arm 1 (sleep education) and Arm 2 (no initial sleep education).
Change in the ESS in Arm 1 (≥2 points)
Time frame: 6 Weeks
The Epworth Sleepiness Scale (ESS) is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the subjects rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the subjects finish the test, add up the values of the responses. The subjects total score is based on a scale of 0 to 24. The scale estimates whether the subjects are experiencing excessive sleepiness that possibly requires medical attention.
Change in PSQI at 6 weeks in Arm 1 (≥3 points)
Time frame: 6 Weeks
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "O" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "O" indicating no difficulty and "21 " indicating severe difficulties in all areas.
3 secondary outcomes
Change in total sleep time
Time frame: 6 weeks after sleep education
Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups
Time frame: 6 weeks after sleep education
Change in heart rate variability in both groups
Time frame: 6 weeks after sleep education
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 39930329Sharma S, Stansbury R, Ramadan J, Rojas E, Finomore V, Pham C, Quan SF, Wen S. Sleep well and live well: Impact of sleep hygiene intervention on sleep duration in a rural community: A randomized controlled trial (THE SWELL STUDY). J Rural Health. 2025 Jan;41(1):e70002. doi: 10.1111/jrh.70002.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education and Delayed Sleep Education in people with Sleep Hygiene, run by West Virginia 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 3 inclusion and 7 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 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in total sleep time (time frame: 6 Weeks). The study lists 3 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 NCT04849572, which also lists 1 linked publication.
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 Feb 2025.