WatchPAT Device Validation Study Compared to Polysomnography

Sleep Clinical Trial

— WPAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188718
• Other study ID #: 17-0827
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• WatchPAT Intervention
Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Itamar-Medical, Israel, Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

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