WatchPAT Device Validation Study Compared to Polysomnography

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)	Up to 10 hours	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.

Secondary Outcome Measures

Name	Time	Method
Oxygen Desaturation Index (ODI)	Up to 10 hours	Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.
Body Position	Up to 10 hours	Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.
Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)	Up to 10 hours	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.
Sleep Staging: Light and Deep	Up to 10 hours	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).
Oxygen Saturation	Up to 10 hours	Amount of oxygen present in the subjects blood via pulse oximetry.
Heart Rate	Up to 10 hours	Documentation of the Subjects heart rate.
Sleep Time (Total)	Up to 10 hours	The Total Sleep Duration time in minutes as recorded by the PSG.
Sleep Staging: REM	Up to 10 hours	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).