Assessment of Sleep by WHOOP in Ambulatory Subjects

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sairam Parthasarathy，University of Arizona

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

January 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PROMIS Sleep Questionnaire Short Form[ Time Frame: Baseline, Day 7, and Day 14 (~2 weeks) ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Sleep duration by sleep logs[ Time Frame: Sleep logs are completed every day by the study participants for the entire two weeks they participate. ]
Sleep duration is defined as the amount of time one spends asleep. This is measured by daily sleep logs.
Sleep duration by actigraphy[ Time Frame: Actigraphy watch will be worn every day by study participants for the entire two weeks they participate. ]
Sleep duration is defined as the amount of time one spends asleep. This is measured by actigraphy.
Sleep Fragmentation[ Time Frame: The WHOOP strap 2.0 is worn continuously throughout the duration of the study (~14 days). ]
Sleep fragmentation is defined as interruptions in sleep. This is measured by the WHOOP strap 2.0.
Heart Rate Variability[ Time Frame: The WHOOP strap 2.0 is worn continuously throughout the duration of the study (~14 days). ]
Heart Rate Variability is defined as the physiological phenomenon of the variation of time intervals between heart beats. This will be measured by the WHOOP Strap 2.0.

Descriptive Information

Brief Title ^ICMJE

Assessment of Sleep by WHOOP in Ambulatory Subjects

Official Title ^ICMJE

Assessment of Sleep by WHOOP in Ambulatory Subjects

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.

Detailed Description

Polysomnography (PSG) is still considered the 'gold standard' for measuring sleep parameters, such as total sleep time, sleep efficiency, and sleep stages (6). However, PSG suffers from key limiting factors for routine care applications irrespective of setting (e.g., home, acute setting, and long term setting). Some of the key limitations of PSG are the high cost, arduous application, intrusiveness to sleep, and requirement of sleep lab and dedicated infrastructure. Wearable technologies could provide a viable alternative to PSG. We are proposing to perform a methodological study aimed at validating the accuracy of WHOOP Strap 2.0 to measure sleep quantity and sleep quality in ambulatory subjects. We will measure sleep by both WHOOP Strap 2.0 and PSG in healthy volunteers (age 18 - 45 years) without self-reported sleep disorders or chronic disabling medical conditions. In ambulatory patients, sleep is usually assessed by the American Academy of Sleep Medicine guidelines which derives from the Rechtschaffen and Kales (R&K) method with good to excellent inter-observer reliability for assessing sleep in the same population; but the Cohen's K range is still 0.68 to 0.82 and much lower for non rapid eye movement (NREM) sleep stage 1 (N1). To account for such inter- and intra-rater reliability issues with the PSG gold-standard, we will only consider sleep stages that are unequivocally scored as a particular stage (light NREM, slow wave sleep [SWS] or REM sleep [R sleep]) by two different observers. Additionally, while there are many devices available to healthy individuals to measure heart rate, there aren't many available that provide a daily heart rate variability statistic. Heart rate variability can be defined as the variation over time of the period between consecutive heart beats. This is due to the balancing regulation effects of the parasympathetic (PNS) and sympathetic (SNS) actions of the autonomic nervous system (ANS). Increased SNS action results in a "fight or flight" response, leading to an accelerated heart rate, while increased PNS activity results in a "rest and digest" response, leading to a decelerated heart rate. The increased variability of heart rate (HR) is an indication of the ANS' control on HR and the heart's ability to respond. WHOOP Strap 2.0 provides users with real-time HR and a daily HRV statistic that is included in other variables calculated measuring daily strain and recovery statistics. We will measure HR and HRV by both WHOOP Strap 2.0 and EKG leads in healthy volunteers (ages 18-45 years) without chronic disabling medical conditions.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will either wear the WHOOP strap 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).
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: Wear WHOOP 1 week prior to sleep study
Participants will wear the WHOOP strap 2.0 7 days prior to their sleep study.
Experimental: Wear WHOOP 1 week after sleep study
Participants will wear the WHOOP strap 2.0 for 7 days after their sleep study.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

January 1, 2019

Estimated Primary Completion Date

January 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sairam Parthasarathy，University of Arizona

Study Sponsor ^ICMJE

University of Arizona

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Sairam Parthasarathy, MD University of Arizona

PRS Account

University of Arizona

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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