Assessment of Sleep by WHOOP in Ambulatory Subjects
Condition: Sleep Quality
Study type: Interventional

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.
    

Intervention name(s): WHOOP Strap 2.0; No Device
Intervention type(s): Device; Other
Intervention description(s): 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.; The WHOOP Strap 2.0 is not worn on the wrist for a seven day period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Other
Keywords: sleep; healthy volunteers; sleep study