Clinical Validation of New Commercial Sleep Monitoring Devices

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fitbit

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.

Group Type ACTIVE_COMPARATOR

Fitbit

Intervention Type DEVICE

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.

Jawbone UP

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.

Group Type ACTIVE_COMPARATOR

Jawbone UP

Intervention Type DEVICE

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.

Microsoft Band

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.

Group Type ACTIVE_COMPARATOR

Microsoft Band

Intervention Type DEVICE

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.

Interventions

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Fitbit

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.

Intervention Type DEVICE

Jawbone UP

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.

Intervention Type DEVICE

Microsoft Band

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No