SleepNCT04727619
Evaluation of SLEEP Program
A study testing SLEEP program in people with Sleep, run by Michigan State University at 1 site in United States.
Trial summary
This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- SLEEP program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants who choose to enroll in the SLEEP program
Who cannot join
- younger than 40 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Sleep Education for Elders Program Evaluation
This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.
- Conditions
- Sleep
- Being tested
- SLEEP program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLEEP programBehavioural
SLEEP is a 6-week educational program designed to improve sleep hygiene and habits.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants who participated in the SLEEP program. Receives: Behavioral: SLEEP program |
| Control | No intervention | Participants who did not participate in the SLEEP program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality: Pittsburgh Sleep Quality Index
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
Measured: immediately after the program
Sleep quality: Pittsburgh Sleep Quality Index
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
Measured: Six months after program completion
Sleep duration
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
Measured: immediately after the program
Sleep duration
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
Measured: Six months after program completion
Daytime sleepiness
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
Measured: immediately after the program
Daytime sleepiness
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
Measured: Six months after program completion
Insomnia symptoms
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
Measured: immediately after the program and six months later
Insomnia symptoms
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
Measured: Six months after program completion
Sleep hygiene habits
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
Measured: immediately after the program
Sleep hygiene habits
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
Measured: Six months after program completion
Secondary outcomes (6)
Sleep-related knowledge
As measured by several questions related to sleep health and hygiene
Measured: immediately after the program
Sleep-related knowledge
As measured by several questions related to sleep health and hygiene
Measured: six months later
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
As measured by questions measuring personal satisfaction with sleep quality and duration
Measured: immediately after the program
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
As measured by questions measuring personal satisfaction with sleep quality and duration
Measured: six months later
Program satisfaction: questions and comments related to program experiences
As measured by questions and comments related to program experiences
Measured: immediately after the program
Program satisfaction: questions and comments related to program experiences
As measured by questions and comments related to program experiences
Measured: six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Tucker, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727619
- Sponsor's protocol ID
- STUDY00003748
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Education for Elders Program Evaluation
- ClinicalTrials.gov ID
- NCT04727619
- Acronym / sponsor ID
- STUDY00003748
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Jan 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 study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: SLEEP programParticipants who participated in the SLEEP program. |
| Control | No intervention | –Participants who did not participate in the SLEEP program. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants who choose to enroll in the SLEEP program
Key exclusion criteria (1 listed)
- younger than 40 years of age
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 programSLEEP is a 6-week educational program designed to improve sleep hygiene and habits. | Behavioural | Experimental |
Primary outcome
Sleep quality: Pittsburgh Sleep Quality Index
Time frame: immediately after the program
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
Sleep quality: Pittsburgh Sleep Quality Index
Time frame: Six months after program completion
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
Sleep duration
Time frame: immediately after the program
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
Sleep duration
Time frame: Six months after program completion
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
Daytime sleepiness
Time frame: immediately after the program
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
Daytime sleepiness
Time frame: Six months after program completion
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
Insomnia symptoms
Time frame: immediately after the program and six months later
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
Insomnia symptoms
Time frame: Six months after program completion
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
Sleep hygiene habits
Time frame: immediately after the program
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
Sleep hygiene habits
Time frame: Six months after program completion
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
6 secondary outcomes
Sleep-related knowledge
Time frame: immediately after the program
Sleep-related knowledge
Time frame: six months later
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
Time frame: immediately after the program
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
Time frame: six months later
Program satisfaction: questions and comments related to program experiences
Time frame: immediately after the program
Program satisfaction: questions and comments related to program experiences
Time frame: six months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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 program in people with Sleep, run by Michigan 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sleep quality: Pittsburgh Sleep Quality Index (time frame: immediately after the program). The study lists 10 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 23 Jan 2026.