WatchPAT Device Validation Study Compared to Polysomnography

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes, Sleep Disorder, Sleep

In brief

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

Key facts

Study ID

NCT03188718

Run by

University of Colorado, Denver

People needed

45

Starts

2017-12-07

Expected to finish

2019-06-01

Last updated by the study team

2021-04-21

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 5 through 12 years of age.
• Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
• snoring,
• witnessed apneas,
• daytime sleepiness, and
• mouth breathing, etc.
• Informed consent obtained.

You may not qualify if…

• Medical conditions that can affect the tonometer reading such as:
• peripheral vascular disease,
• cyanotic heart disease,
• systemic hypertension, and
• sickle cell crisis.
• Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
• autism spectrum disorder,
• Trisomy 21, and
• neurodevelopmental disorders.
• History of neuromuscular malformation
• History of current supplemental oxygen use
• History of current vasoactive, cardiac or seizure medication use
• Inability or unwillingness to provide informed consent

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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