Research Framework Exploring Sleep Health

NCT05197738 | Recruiting

• 1 other identifier: IRB-21-7863
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire 9

  Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression

  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

  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

  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 as the difference between BMI reported at the beginning of the study and at the two-month mark.

Study Arms (11)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General adult population.

You may qualify if:

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

You may not qualify if:

• In-ability to consent

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Research Institute

La Jolla, California, 92037, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An eventual goal of this study is to include a genetic assessment

MeSH Terms

Conditions

Sleep Apnea Syndromes; Obesity

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuti Jaiswal, MD, PhD

  Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuti Jaiswal, MD, PhD

CONTACT

858-784-2169; stuti@scripps.edu

Ed Ramos, PhD

CONTACT

eramos@scripps.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Molecular Medicine

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 19, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2041
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

US (1)