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Trial record 1 of 1 for:    NCT03692195
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Assessment of Sleep by WHOOP in Ambulatory Subjects

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ClinicalTrials.gov Identifier: NCT03692195
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
WHOOP Inc.
Information provided by (Responsible Party):
Sairam Parthasarathy, University of Arizona

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.


Condition or disease Intervention/treatment Phase
Sleep Quality Device: WHOOP Strap 2.0 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Sleep by WHOOP in Ambulatory Subjects
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: Wear WHOOP 1 week prior to sleep study
Participants will wear the WHOOP strap 2.0 7 days prior to their sleep study.
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692195


Contacts
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Contact: Chris Morton (520) 626-8457 cjmorton@email.arizona.edu
Contact: Sarah Berryhill, BS (520) 626-4838 smarkows@email.arizona.edu

Locations
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United States, Arizona
Center for Sleep and Circadian Sciences Recruiting
Tucson, Arizona, United States, 85719
Contact: Christopher Morton       cjmorton@email.arizona.edu   
Contact: Sarah         
Sponsors and Collaborators
University of Arizona
WHOOP Inc.
Investigators
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Principal Investigator: Sairam Parthasarathy, MD University of Arizona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sairam Parthasarathy, Professor of Medicine, University of Arizona
ClinicalTrials.gov Identifier: NCT03692195    
Other Study ID Numbers: WHOOP00001
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sairam Parthasarathy, University of Arizona:
sleep
healthy volunteers
sleep study