WatchPAT Device Validation Study Compared to Polysomnography

NCT03188718 | Completed Results FDA Device

• 1 other identifier: 17-0827
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea Syndromes; Sleep Disorder; Sleep

Keywords

Polysomnogram; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)

  Up to 10 hours

• Oxygen Desaturation Index (ODI)

  Up to 10 hours

• Sleep Staging: Light and Deep

  Up to 10 hours

• Oxygen Saturation

  Up to 10 hours

• Heart Rate

  Up to 10 hours

Study Arms (1)

WatchPAT Intervention

OTHER

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

Device: WatchPAT Intervention

Interventions

WatchPAT Intervention DEVICE

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

WatchPAT Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Kaiser Permanente: collaborator
• Itamar-Medical, Israel: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Michelle Sobremonte-King, MD
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Michelle Sobremonte-King, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Ann Halbower, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded to the subject's diagnosis
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 15, 2017
• Study Start: December 7, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)