Assessment of Sleep by WHOOP in Ambulatory Subjects

NCT03692195 | Completed

• 1 other identifier: WHOOP00001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Polysomnography (PSG) is considered the 'gold standard' for objectively measuring different parameters of sleep, including total sleep time, quality of sleep, and distinguishing between sleep stages. However, PSG is costly, and tends to be burdensome in terms of set-up time and invasiveness during sleep. Wearable sleep-monitoring devices could prove to be a more practical alternative to PSG. Additionally, while EKG leads are typically what is utilized to measure heart rate (HR) and heart rate variability (HRV) throughout the night in a PSG set-up, every day-use HR monitors are also beneficial for individuals to evaluate their cardiovascular activity during different types of physical activities (including every day activities, exercise, and sleep), as well as their heart's ability to "recover" from a given activity. The investigators propose to study the effect of the WHOOP Strap 2.0 device on sleep perception and perform a methodological study to validate the accuracy of the the WHOOP Strap 2.0 device when measuring HR accuracy and HRV accuracy, and sleep quality and quantity with respect to PSG in healthy volunteers with no self-reported sleep disorders or debilitating medical conditions.

Conditions

Sleep Quality

Keywords

sleep; healthy volunteers; sleep study

Outcome Measures

Primary Outcomes (1)

• PROMIS Sleep Questionnaire Short Form

  An 8-item questionnaire used to assess subjective sleep disturbance in individuals 18 and older. Each questionnaire item addresses an aspect about sleep quality that is rated by the respondent on a 5-point scale (i.e., 1= Not at all \& 5 = Very Much). Change in PROMIS score will be assessed between Baseline, Day 7, and Day 14.

  Baseline, Day 7, and Day 14 (~2 weeks)

Secondary Outcomes (7)

• Sleep duration by WHOOP Strap 2.0

  The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.

• Sleep Fragmentation

  The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.

• Heart Rate Variability

  The WHOOP strap 2.0 is worn continuously throughout the duration of the study (~14 days).

• Sleep Staging

  The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.

• Sleep Versus Wake Detection

  The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.

Study Arms (2)

Week WHOOP is worn

EXPERIMENTAL

Participants will wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study.

Device: WHOOP Strap 2.0

Week WHOOP is not worn

PLACEBO COMPARATOR

Participants will not wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study.

Other: No Device

Interventions

WHOOP Strap 2.0 DEVICE

The WHOOP Strap 2.0 is worn on the wrist, continuously throughout the 7-day period of which participants will be assigned. It measures heart rate, sleep, strain, and recovery.

Week WHOOP is worn

No Device OTHER

The WHOOP Strap 2.0 is not worn on the wrist for a seven day period.

Week WHOOP is not worn

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide informed consent
• Willingness to undergo a polysomnography electrode hook-up and wear a WHOOP strap 2.0.
• Healthy volunteers

You may not qualify if:

• Presence of untreated sleep disorder that requires diagnostic testing and treatment (insomnia, obstructive sleep apnea, narcolepsy, restless leg syndrome, REM sleep behavior disorder, or circadian rhythm sleep disorders).
• Apnea-Hypopnea index greater than or equal to 15 per hour as per AASM guidelines
• Active substance abuse or alcoholism
• Pregnancy or lactation
• Currently taking sedative medications
• Chronic medical conditions such as hypertension, diabetes mellitus, cardiac disorders, arthritis, or other chronic medical conditions
• BMI greater than 26

Sponsors & Collaborators

• University of Arizona: lead
• Whoop Inc.: collaborator

Study Sites (1)

Center for Sleep and Circadian Sciences

Tucson, Arizona, 85719, United States

Location

Related Publications (1)

• Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.

  PMID: 32043961 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Study participants will either wear the WHOOP strap 2.0 one week before their sleep study (as well as the night of the sleep study) or one week after their sleep study (as well as the night of the sleep study). This is a within subjects design to compare sleep patterns the week subjects are wearing the Whoop strap 2.0 with the week subjects do not wear the Whoop Strap 2.0. Participants either wear the WHOOP strap 2.0 one week before or one week after their sleep study in order to counterbalance for ordering effects.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 2, 2018
• Study Start: November 1, 2018
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)