Research Framework Exploring Sleep Health

NCT ID: NCT05197738

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2041-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Sleep Apnea Obesity Mood

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk OSA

Cohort of individuals found to sleep have scores categorized as "High risk," on the Berlin questionnaire.

No interventions assigned to this group

Low risk OSA

Cohort of individuals found to sleep have scores categorized as "Low risk," on the Berlin questionnaire.

No interventions assigned to this group

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.

No interventions assigned to this group

Long sleepers

Cohort of individuals found to have average sleep duration of \>9 hours per night.

No interventions assigned to this group

Average lengths leepers

Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night

No interventions assigned to this group

Regular sleepers

Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration.

No interventions assigned to this group

Irregular sleepers

Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration

No interventions assigned to this group

Severe insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe

No interventions assigned to this group

Moderate insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate

No interventions assigned to this group

No insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low

No interventions assigned to this group

Increased social jet lag

Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Residing within the United States
* Ability to use the REFRESH app on the participant's own smartphone device

Exclusion Criteria

* In-ability to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Stuti Jaiswal

Assistant Professor of Molecular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuti Jaiswal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Scripps Research Institute

Locations

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Scripps Research Institute

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stuti Jaiswal, MD, PhD

Role: CONTACT

858-784-2169

Ed Ramos, PhD

Role: CONTACT

Facility Contacts

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Stuti J Jaiswal, MD, PhD

Role: primary

Other Identifiers

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IRB-21-7863

Identifier Type: -

Identifier Source: org_study_id

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