SleepREFRESHNCT05197738
Research Framework Exploring Sleep Health
An observational study of Sleep and Sleep Apnea, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Apnea, Obesity
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 31 Dec 2041
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General adult population.
Who may be able to join
- Age ≥ 18 years
- Residing within the United States
- Ability to use the REFRESH app on the participant's own smartphone device
Who cannot join
- In-ability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ed Ramos, PhD contact
United States1 site, 1 recruiting
- Recruiting
Scripps Research Institute
La Jolla, California, 92037
Stuti J Jaiswal, MD, PhD
About this study
This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.
- Conditions
- Sleep, Sleep Apnea, Obesity, Mood
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High risk OSA | Cohort of individuals found to sleep have scores categorized as "High risk," on the Berlin questionnaire. | |
| Low risk OSA | Cohort of individuals found to sleep have scores categorized as "Low risk," on the Berlin questionnaire. | |
| Short sleepers | Cohort of individuals found to have average sleep duration of < 7 hours per night. Individuals who sleep on average less than 6 hours per night will further be sub-categorized as very short sleeprs. | |
| Long sleepers | Cohort of individuals found to have average sleep duration of >9 hours per night. | |
| Average lengths leepers | Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night | |
| Regular sleepers | Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration. | |
| Irregular sleepers | Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration | |
| Severe insomnia risk | Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe | |
| Moderate insomnia risk | Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate | |
| No insomnia risk | Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low | |
| Increased social jet lag | Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9
Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression
Measured: Administered one time at enrollment
Bi-weekly mood scores
Mood scores based on an 11 point rating scale, with higher scores indicated a better mood
Measured: Averaged bi-weekly over a two month period
Subjective sleep quality
Biweekly assessment of refreshing sleep quality on an 11 point rating scale, with higher scores indicated better subjective sleep from the participant
Measured: Averaged bi-weekly over a two month period
Change in BMI
Based on standard BMI categories; calculated based on self-reported data of height and weight
Measured: Measured as the difference between BMI reported at the beginning of the study and at the two-month mark.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2041 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuti Jaiswal, Scripps Translational Science Institute
- Investigators
- Stuti Jaiswal, MD, PhD, Principal investigator, Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197738
- Sponsor's protocol ID
- IRB-21-7863
- Acronym
- REFRESH
- Status last verified
- Jun 2024
- First submitted
- 16 Dec 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Framework Exploring Sleep Health
- ClinicalTrials.gov ID
- NCT05197738
- Acronym / sponsor ID
- REFRESH / IRB-21-7863
- Conditions
- Sleep, Sleep Apnea, Obesity, Mood
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 19 Jan 2022 (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 is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| High risk OSA | – | –Cohort of individuals found to sleep have scores categorized as "High risk," on the Berlin questionnaire. |
| Low risk OSA | – | –Cohort of individuals found to sleep have scores categorized as "Low risk," on the Berlin questionnaire. |
| Short sleepers | – | –Cohort of individuals found to have average sleep duration of < 7 hours per night. Individuals who sleep on average less than 6 hours per night will further be sub-categorized as very short sleeprs. |
| Long sleepers | – | –Cohort of individuals found to have average sleep duration of >9 hours per night. |
| Average lengths leepers | – | –Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night |
| Regular sleepers | – | –Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration. |
| Irregular sleepers | – | –Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration |
| Severe insomnia risk | – | –Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe |
| Moderate insomnia risk | – | –Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate |
| No insomnia risk | – | –Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low |
| Increased social jet lag | – | –Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General adult population.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Residing within the United States
- Ability to use the REFRESH app on the participant's own smartphone device
Key exclusion criteria (1 listed)
- In-ability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Health Questionnaire 9
Time frame: Administered one time at enrollment
Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression
Bi-weekly mood scores
Time frame: Averaged bi-weekly over a two month period
Mood scores based on an 11 point rating scale, with higher scores indicated a better mood
Subjective sleep quality
Time frame: Averaged bi-weekly over a two month period
Biweekly assessment of refreshing sleep quality on an 11 point rating scale, with higher scores indicated better subjective sleep from the participant
Change in BMI
Time frame: Measured as the difference between BMI reported at the beginning of the study and at the two-month mark.
Based on standard BMI categories; calculated based on self-reported data of height and weight
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 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ed Ramos, PhD contact
Stuti Jaiswal, MD, PhD principal investigator
Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Sleep Apnea, run by Scripps Translational Science Institute 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 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: looking for participants now, as of the sponsor's last update on 28 Jun 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?
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?
Contact Stuti Jaiswal, MD, PhD (858-784-2169, stuti@scripps.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (time frame: Administered one time at enrollment). The study lists 4 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 28 Jun 2024.