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COMPLETED
NCT03670914
NA

Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications

Sponsor: Kaiser Permanente

View on ClinicalTrials.gov

Summary

The present study is a prospective, single cohort study involving patients on narcotic medications, undergoing overnight sleep studies in the clinical sleep laboratory. The main hypothesis for the study is that the the frequency of sleep respiratory events (including central apneas) identified by a home sleep apnea test (HSAT) device (WatchPAT200U (wp200U) with centrals; Itamar Medical Ltd.) will significantly correlate with in-lab polysomnography (gold standard).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2019-08-08

Completion Date

2025-03-13

Last Updated

2026-07-20

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

WatchPAT 200

The WatchPAT200 device has been approved by the Food and Drug Administration (FDA) for testing sleep related disorders in patients ages 17 and older. They are widely used with thousands of studies performed in the United States to validate the devices accuracy and efficacy. It is also routinely used in many other countries. The devices are not currently being used for patients who are currently taking narcotic medications at Kaiser Permanente. Therefore, we are asking patients to simultaneously wear this device during an in-lab study, so we can test how effective and accurate the WatchPAT 200 is in diagnosing sleep breathing disorders in patients on narcotic medications.

Locations (1)

Sleep Center; San Bernardino County Medical Center, Kaiser Permanente

Fontana, California, United States