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Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications (WP-NARC001)

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ClinicalTrials.gov Identifier: NCT03670914
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Hwang, MD, Kaiser Permanente

Brief 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).

Condition or disease Intervention/treatment Phase
Narcotic Use Central Sleep Apnea Diagnostic Test: WatchPAT 200 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective single cohort study that will evaluate the efficacy of the WatchPAT200 device by comparing it to an in-lab polysomnography.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: WatchPAT 200 and In-Lab Study
Patients who are referred to the sleep center for an overnight study that are narcotic users will be offered to the opportunity to participate in the study. Patients who fulfill the inclusion exclusion criteria and have given informed consent will undergo a standard in-lab polysomnography while simultaneously wearing the WatchPAT200 device.
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.




Primary Outcome Measures :
  1. Accuracy of Central Sleep Apnea Events [ Time Frame: 1 year ]
    Compare the efficacy of the WatchPAT200 in detecting narcotic based central respiratory events to the manual scoring of the in-lab polysomnography that serves as a "gold standard".

  2. Accuracy of Other Various Sleep Metrics [ Time Frame: 1 year ]
    Compare the efficacy of the WatchPAT200 in detecting narcotic based oxygen, body position, and sleep-wake events to the in-lab polysomnography.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Kaiser Permanente member
  • Patient is able to read, understand and sign the informed consent form.
  • Subject on current narcotic prescription with of at least 4 nights/week (subject will be asked on night of PSG if they took narcotic medication and specific medication taken)

Exclusion Criteria

  • Finger deformity that precludes adequate sensor appliance
  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
  • Patients that are oxygen dependent
  • Patients with Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <70%, obesity hypoventilation syndrome, neuromuscular weakness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670914


Contacts
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Contact: Dennis Hwang, MD 909-427-4432 ext Option 4 dennis.x.hwang@kp.org
Contact: Jessica Arguelles, BS 909-427-3032 jessica.arguelles@kp.org

Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Dennis Hwang, MD Kaiser Permanente Fontana Medical Sleep Center

Publications:
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Responsible Party: Dennis Hwang, MD, Department Medical Director, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03670914     History of Changes
Other Study ID Numbers: WatchPAT200-NARC001
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dennis Hwang, MD, Kaiser Permanente:
Sleep Disorder Breathing
Central Sleep Apnea
Narcotics
Home Sleep Apnea Testing Device
WatchPAT 200
In-Lab Polysomnography
Comparison
Accuracy
Efficacy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents