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Completed

NCT Number: NCT03188718

WatchPAT Device Validation Study Compared to Polysomnography

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

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Key information

Conditions

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

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WatchPAT Intervention

Device

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

Primary outcomes

  1. Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)

    Time frame: Up to 10 hours

    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 outcomes

  1. Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)

    Time frame: Up to 10 hours

    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.

  2. Oxygen Desaturation Index (ODI)

    Time frame: Up to 10 hours

    Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.

  3. Sleep Staging: Light and Deep

    Time frame: Up to 10 hours

    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).

  4. Oxygen Saturation

    Time frame: Up to 10 hours

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

  5. Heart Rate

    Time frame: Up to 10 hours

    Documentation of the Subjects heart rate.

  6. Body Position

    Time frame: Up to 10 hours

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

  7. Sleep Time (Total)

    Time frame: Up to 10 hours

    The Total Sleep Duration time in minutes as recorded by the PSG.

  8. Sleep Staging: REM

    Time frame: Up to 10 hours

    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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Itamar-Medical, Israel
  • Kaiser Permanente

Registry information

Official study title

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

Acronym: WPAT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2017
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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