Sleep QualityNCT03692195
Assessment of Sleep by WHOOP in Ambulatory Subjects
A study testing WHOOP Strap 2.0 and No Device in people with Sleep Quality, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- WHOOP Strap 2.0 and No Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 7 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide informed consent
- Willingness to undergo a polysomnography electrode hook-up and wear a WHOOP strap 2.0.
- Healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Sleep and Circadian Sciences
Tucson, Arizona, 85719
About this study
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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- WHOOP Strap 2.0, No Device
- Keywords
- sleep, healthy volunteers, sleep study
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOOP Strap 2.0Device
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.
No DeviceOther
The WHOOP Strap 2.0 is not worn on the wrist for a seven day period.
| Study group | Role | What they receive |
|---|---|---|
| Week WHOOP is worn | Experimental | Participants will wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study. Receives: Device: WHOOP Strap 2.0 |
| Week WHOOP is not worn | Placebo comparator | Participants will not wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study. Receives: Other: No Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Questionnaire Short Form
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.
Measured: Baseline, Day 7, and Day 14 (~2 weeks)
Secondary outcomes (7)
Sleep duration by WHOOP Strap 2.0
Sleep duration is defined as the amount of time one spends asleep. This is measured by the WHOOP Strap 2.0 and is compared to Polysomnography, the gold standard for measuring sleep parameters and sleep stages.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Sleep Fragmentation
Sleep fragmentation is defined as interruptions in sleep. This is measured by the WHOOP Strap 2.0 and is compared to Polysomnography, the gold standard for measuring sleep parameters and sleep stages.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Heart Rate Variability
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.
Measured: The WHOOP strap 2.0 is worn continuously throughout the duration of the study (~14 days).
Sleep Staging
The WHOOP Strap 2.0 differentiates between light sleep, slow wave sleep, and REM sleep. This will be compared to polysomnography, which is the gold standard of measuring sleep staging and sleep parameters.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Sleep Versus Wake Detection
The WHOOP Strap 2.0 differentiates between sleep and wake status. This will be compared to polysomnography, which is the gold standard of measuring sleep staging and sleep parameters.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Heart Rate Accuracy
The WHOOP Strap 2.0 collects heart rate. This will be compared to the known gold standard of Electrocardiogram electrode leads as part of the polysomnography montage.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Respiratory Rate
The WHOOP Strap 2.0 collects respiratory rate. This will be compared to the nasal cannula respiratory rate which is part of the polysomnography montage.
Measured: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Nov 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Whoop Inc.
- Responsible party
- Principal investigator, Sairam Parthasarathy, University of Arizona
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692195
- Sponsor's protocol ID
- WHOOP00001
- Status last verified
- Aug 2021
- First submitted
- 27 Sep 2018
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.
PubMed 32043961
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep by WHOOP in Ambulatory Subjects
- ClinicalTrials.gov ID
- NCT03692195
- Acronym / sponsor ID
- WHOOP00001
- Conditions
- Sleep Quality
- Keywords
- sleep, healthy volunteers, sleep study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Whoop Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Week WHOOP is worn | Experimental | Device: WHOOP Strap 2.0Participants will wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study. |
| Week WHOOP is not worn | Placebo comparator | Other: No DeviceParticipants will not wear the WHOOP strap 2.0 either 7 days prior to or 7 days after their sleep study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ability to provide informed consent
- Willingness to undergo a polysomnography electrode hook-up and wear a WHOOP strap 2.0.
- Healthy volunteers
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOOP Strap 2.0The 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. | Device | Week WHOOP is worn |
| No DeviceThe WHOOP Strap 2.0 is not worn on the wrist for a seven day period. | Other | Week WHOOP is not worn |
Primary outcome
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.
7 secondary outcomes
Sleep duration by WHOOP Strap 2.0
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Sleep Fragmentation
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Heart Rate Variability
Time frame: The WHOOP strap 2.0 is worn continuously throughout the duration of the study (~14 days).
Sleep Staging
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Sleep Versus Wake Detection
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Heart Rate Accuracy
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Respiratory Rate
Time frame: The WHOOP Strap 2.0 is worn on day 7 of the study. Polysomnography occurs on day 7 of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 32043961Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sairam Parthasarathy, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHOOP Strap 2.0 and No Device in people with Sleep Quality, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep Questionnaire Short Form (time frame: Baseline, Day 7, and Day 14 (~2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.