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Assessment of Sleep by WHOOP in Ambulatory Subjects

NCT03692195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-08-09

No results posted yet for this study

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

Interventions

DEVICE

WHOOP Strap 2.0

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.

OTHER

No Device

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

Sponsors & Collaborators

  • Whoop Inc.

    collaborator INDUSTRY

  • University of Arizona

    lead OTHER

Principal Investigators

  • Sairam Parthasarathy, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-06-07
Completion
2019-06-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03692195 on ClinicalTrials.gov