Clinical trial NCT02779543: Clinical Validation of New Commercial Sleep Monitoring Devices
Official title: Clinical Validation of New Commercial Sleep Monitoring Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: In lab sleep studies
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2016-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep assessment. This research is being done because if proven to accurately analyze sleep,these devices may make conducting in-home sleep studies easier and more affordable in the future.

Detailed description: This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), considered the gold standard assessment for sleep physiology. The investigators emphasize here that the commercial sleep monitoring devices (Fitbit, Jawbone UP, and Microsoft Band) are used in addition to PSG and not in place of it. Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Data will be transferred from the sleep monitoring device(s) for later statistical analysis and comparison with scored polysomnogram. Device(s) will be cleaned (using antiseptic wipes), reset,recharged, and otherwise prepared for reuse.

Eligibility criteria: Inclusion Criteria:

* Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.

Exclusion Criteria:

* Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
* Under 18 or over 80 years old.
* Pregnancy
* Unable to provide informed consent.

Primary outcomes:
measure: Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.
timeFrame: 1 night, approximately 9 hours.
Secondary outcomes:
measure: Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.
timeFrame: 1 night, approximately 9 hours.
measure: Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.
timeFrame: 1 night, approximately 9 hours.
measure: Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.
timeFrame: 1 night, approximately 9 hours.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine Center for Sleep Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ana Krieger, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References: