WatchPAT Compared to PSG at 8500'

January 29, 2020 updated by: Itamar-Medical, Israel

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

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'.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Woodland Park, Colorado, United States, 80863
        • Mountain Sleep Diagnostics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to a sleep lab for full PSG.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
Time Frame: 8 months.
8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Itamar-Medical, Israel

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2018

Primary Completion (ACTUAL)

August 14, 2018

Study Completion (ACTUAL)

December 10, 2019

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP200U-Altitude-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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