NCT03692195

Assessment of Sleep by WHOOP in Ambulatory Subjects

Completed NA Last updated 9 August 2021

What this trial tests

NA trial testing WHOOP Strap 2.0 in Sleep Quality in 35 participants. Completed in 7 June 2019.

Timeline

1 November 2018

Primary endpoint
7 June 2019

7 June 2019

Quick facts

Lead sponsor	University of Arizona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	35
Start date	1 November 2018
Primary completion	7 June 2019
Estimated completion	7 June 2019
Sites	1 location across United States

Drugs / interventions tested

• WHOOP Strap 2.0
• No Device

Conditions studied

• Sleep Quality — all drugs for Sleep Quality →

Sponsor

University of Arizona

Who can join

Adults 18 to 45, any sex, with Sleep Quality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study.
   Berryhill S, Morton CJ, Dean A, Berryhill A, et al · · 2020 · cited 102× · PMID 32043961 · DOI 10.5664/jcsm.8356