WatchPAT Compared to PSG at 8500'

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04249011

Enrollment

Registered

2020-01-30

Start date

2018-05-02

Completion date

2019-12-10

Last updated

2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder; Breathing-Related

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

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.

Design outcomes

Primary

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

Countries

United States

Outcome results