CompletedNot Applicable

WatchPAT Compared to PSG at 8500'

United States22 participantsStarted 2018-05-02

Plain-language summary

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'.

Who can participate

Age range17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 8 months.

Trial details

NCT IDNCT04249011

SponsorItamar-Medical, Israel

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-08-14

View on ClinicalTrials.gov More Sleep Disorder; Breathing-Related trials