WatchPAT Compared to PSG at 8500'

NCT ID: NCT04249011

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-02

Study Completion Date

2019-12-10

Brief Summary

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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'.

Detailed Description

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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"

Conditions

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Sleep Disorder; Breathing-Related

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Itamar-Medical, Israel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koby Sheffy, Phd

Role: STUDY_DIRECTOR

Itamar-Medical, Israel

Locations

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Mountain Sleep Diagnostics

Woodland Park, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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WP200U-Altitude-001

Identifier Type: -

Identifier Source: org_study_id

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