Clinical Validation of New Commercial Sleep Monitoring Devices

Sleep Apnea Clinical Trial

Official title:

Clinical Validation of New Commercial Sleep Monitoring Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779543
• Other study ID #: 1509016542
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: March 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine Center for Sleep Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.	Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).	1 night, approximately 9 hours.
Secondary	Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.	Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).	1 night, approximately 9 hours.
Secondary	Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.	Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)	1 night, approximately 9 hours.
Secondary	Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.	Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)	1 night, approximately 9 hours.