WatchPAT Device Validation Study Compared to Polysomnography

University of Colorado, Denver45 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Apnea Syndromes Sleep Disorder Sleep

Interventions

WatchPAT InterventionDEVICE

Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)

Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.

Time frame: Up to 10 hours

Secondary Outcomes

Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)

Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep.

Time frame: Up to 10 hours

Oxygen Desaturation Index (ODI)

Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.

Time frame: Up to 10 hours

Sleep Staging: Light and Deep

Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).

Time frame: Up to 10 hours

Oxygen Saturation

Amount of oxygen present in the subjects blood via pulse oximetry.

Time frame: Up to 10 hours

Heart Rate

Documentation of the Subjects heart rate.

Time frame: Up to 10 hours

Body Position

Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.

Data from ClinicalTrials.gov

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