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NCT04249011 Clinical Trial

WatchPAT Compared to PSG at 8500'

Sleep Disorder; Breathing-Related Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04249011
Other study ID # WP200U-Altitude-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date December 10, 2019

Study information
Verified date January 2020
Source Itamar-Medical, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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'.

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"

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date December 10, 2019
Est. primary completion date August 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mountain Sleep Diagnostics Woodland Park Colorado

Sponsors (1)
Lead Sponsor Collaborator
Itamar-Medical, Israel

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG. 8 months.
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