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OpenTrials
Completed

NCT Number: NCT04249011

WatchPAT Compared to PSG at 8500'

Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

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Key information

Conditions

Sleep Disorder; Breathing-Related Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mountain Sleep Diagnostics

Woodland Park, Colorado, 80863, United States

About this study

The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and females ≥ age 17yrs
  • Subject is able to read understand and sign the informed consent form.
  • Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.

Exclusion criteria

  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
  • Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.

Treatment and study plan

Primary outcomes

  1. Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.

    Time frame: 8 months.

Sponsors and collaborators

Lead sponsor

Itamar-Medical, Israel

Industry

Registry information

Official study title

Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 30, 2020
Registry last updated
Jan 30, 2020

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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