WatchPAT Compared to PSG at 8500'

Itamar-Medical, Israel22 enrolled

Overview

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'.

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"

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep Disorder; Breathing-Related

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mountain Sleep Diagnostics

Woodland Park, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: 8 months.

Data from ClinicalTrials.gov

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