WatchPAT Device Validation Study Compared to Polysomnography (WPAT)

Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep
• Intervention / Treatment: Device: WatchPAT Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WatchPAT Intervention; Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).	Device: WatchPAT Intervention; Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Up to 10 hours
Oxygen Saturation	Amount of oxygen present in the subjects blood via pulse oximetry.	Up to 10 hours
Heart Rate	Documentation of the Subjects heart rate.	Up to 10 hours
Body Position	Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.	Up to 10 hours
Sleep Time (Total)	The Total Sleep Duration time in minutes as recorded by the PSG.	Up to 10 hours
Sleep Staging: REM	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).	Up to 10 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Kaiser Permanente; Itamar-Medical, Israel
• Investigators: Principal Investigator: Michelle Sobremonte-King, MD, University of Colorado, Denver; Principal Investigator: Ann Halbower, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Sleep Disordered Breathing; Polysomnogram
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Wake Disorders
• Other Study ID Numbers: 17-0827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No