WatchPAT Compared to PSG at 8500'

Completed

• Conditions: Sleep Disorder; Breathing-Related

• Registration Number: NCT04249011
• Lead Sponsor: Itamar-Medical, Israel

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'.

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 Timeline

• Study Start: 2018-05-02
• Primary Completion: 2018-08-14
• Study Completion: 2019-12-10
• Status Verified: 2020-01
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.	8 months.

Trial Locations

Locations (1)

Mountain Sleep Diagnostics; 🇺🇸 Woodland Park, Colorado, United States