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WatchPAT Device Validation Study Compared to Polysomnography (WPAT)

Primary Purpose

Sleep Apnea Syndromes, Sleep Disorder, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WatchPAT Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndromes focused on measuring Polysomnogram, Sleep Disordered Breathing

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

WatchPAT Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2017
Last Updated
April 20, 2021
Sponsor
University of Colorado, Denver
Collaborators
Kaiser Permanente, Itamar-Medical, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT03188718
Brief Title
WatchPAT Device Validation Study Compared to Polysomnography
Acronym
WPAT
Official Title
Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Kaiser Permanente, Itamar-Medical, Israel

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Disorder, Sleep
Keywords
Polysomnogram, Sleep Disordered Breathing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Blinded to the subject's diagnosis
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WatchPAT Intervention
Arm Type
Other
Arm Description
Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).
Intervention Type
Device
Intervention Name(s)
WatchPAT Intervention
Intervention Description
Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.
Primary Outcome Measure Information:
Title
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
Description
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 Outcome Measure Information:
Title
Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)
Description
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
Title
Oxygen Desaturation Index (ODI)
Description
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
Title
Sleep Staging: Light and Deep
Description
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
Title
Oxygen Saturation
Description
Amount of oxygen present in the subjects blood via pulse oximetry.
Time Frame
Up to 10 hours
Title
Heart Rate
Description
Documentation of the Subjects heart rate.
Time Frame
Up to 10 hours
Title
Body Position
Description
Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.
Time Frame
Up to 10 hours
Title
Sleep Time (Total)
Description
The Total Sleep Duration time in minutes as recorded by the PSG.
Time Frame
Up to 10 hours
Title
Sleep Staging: REM
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Sobremonte-King, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Halbower, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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WatchPAT Device Validation Study Compared to Polysomnography

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