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WatchPAT Compared to PSG at 8500'

Sponsor
Itamar-Medical, Israel (Industry)
Overall Status
Completed
CT.gov ID
NCT04249011
Collaborator
(none)
22
Enrollment
1
Location
19.3
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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'.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.
    Actual Study Start Date :
    May 2, 2018
    Actual Primary Completion Date :
    Aug 14, 2018
    Actual Study Completion Date :
    Dec 10, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG. [8 months.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mountain Sleep Diagnostics Woodland Park Colorado United States 80863

    Sponsors and Collaborators

    • Itamar-Medical, Israel

    Investigators

    • Study Director: Koby Sheffy, Phd, Itamar-Medical, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Itamar-Medical, Israel
    ClinicalTrials.gov Identifier:
    NCT04249011
    Other Study ID Numbers:
    • WP200U-Altitude-001
    First Posted:
    Jan 30, 2020
    Last Update Posted:
    Jan 30, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Wake Disorders

    Study Results

    No Results Posted as of Jan 30, 2020