WatchPAT Device Validation Study Compared to Polysomnography (WPAT)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep

Treatments: Device: WatchPAT Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03188718

17-0827

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 5 through 12 years of age.

2. 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.

3. Informed consent obtained.

Exclusion criteria

1. Medical conditions that can affect the tonometer reading such as:

   • peripheral vascular disease,
   • cyanotic heart disease,
   • systemic hypertension, and
   • sickle cell crisis.

2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:

   • autism spectrum disorder,
   • Trisomy 21, and
   • neurodevelopmental disorders.

3. History of neuromuscular malformation

4. History of current supplemental oxygen use

5. History of current vasoactive, cardiac or seizure medication use

6. Inability or unwillingness to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

WatchPAT Intervention

Other group

Description:

Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).

Treatment:

Device: WatchPAT Intervention