MedTrace Logo

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

NCT03670914 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-07-06

No results posted yet for this study

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).

Conditions

  • Narcotic Use
  • Central Sleep Apnea

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.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Dennis Hwang, MD · Kaiser Permanente Fontana Medical Sleep Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2023-07-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670914 on ClinicalTrials.gov