WatchPAT Device Validation Study Compared to Polysomnography

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2019-06-01

Brief Summary

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

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Detailed Description

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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

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Sleep Apnea Syndromes Sleep Disorder Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Blinded to the subject's diagnosis

Study Groups

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WatchPAT Intervention

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

Group Type OTHER

WatchPAT Intervention

Intervention Type DEVICE

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

Interventions

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WatchPAT Intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes