NCT03188718

WatchPAT Device Validation Study Compared to Polysomnography

Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Validation study of a novel sleep Device compared to a traditional sleep study.

Detailed description

This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.

Conditions

• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep

Interventions

Type	Name	Description
DEVICE	WatchPAT Intervention	Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.

Timeline

• Start date: 2017-12-07
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2017-06-15
• Last updated: 2021-04-21
• Results posted: 2021-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study