WatchPAT Device Validation Study Compared to Polysomnography


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Verified June 2017 by University of Colorado, Denver

Sponsor:

Collaborators:

Kaiser Permanente

Itamar-Medical, Israel

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT03188718

First received: June 1, 2017

Last updated: June 14, 2017

Last verified: June 2017

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

Sleep Apnea Syndromes
Sleep Disorder
Sleep
Device: WatchPAT Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:

Blinded to the subject’s diagnosis

Primary Purpose: Diagnostic

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

Primary Outcome Measures:

Secondary Outcome Measures:

  • Peripheral arterial tone respiratory disturbance index (PRDI) [ Time Frame: At 104 Weeks ]

    Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter.

  • Oxygen desaturation index (ODI) [ Time Frame: At 104 Weeks ]

    Peripheral index from the device sensor similar to a pulse oximeter.

  • Sleep Staging and Sleep Time [ Time Frame: At 104 Weeks ]

    Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram and standard of care indices.

  • Oxygen saturation [ Time Frame: At 104 Weeks ]

    Amount of oxygen present in the subjects blood via pulse oximetry.

  • Heart rate [ Time Frame: At 104 Weeks ]

    Documentation of the Subjects heart rate.

  • Body Position [ Time Frame: At 104 Weeks ]

    Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.

Estimated Enrollment: 60
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 4 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 or craniofacial 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03188718

University of Colorado, Denver

Kaiser Permanente

Itamar-Medical, Israel

Principal Investigator: Michelle Sobremonte-King, MD University of Colorado, Denver
Principal Investigator: Ann Halbower, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03188718     History of Changes
Other Study ID Numbers: 17-0827
Study First Received: June 1, 2017
Last Updated: June 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Colorado, Denver:

Polysomnogram
Sleep Disordered Breathing

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Sleep Wake Disorders
Parasomnias
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on June 15, 2017