Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications (WP-NARC001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03670914|
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Narcotic Use Central Sleep Apnea||Diagnostic Test: WatchPAT 200||Not Applicable|
Show Detailed Description
|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)|
|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|
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.
- 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".
- 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.
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
|Contact: Dennis Hwang, MD||909-427-4432 ext Option email@example.com|
|Contact: Jessica Arguelles, BSfirstname.lastname@example.org|
|Principal Investigator:||Dennis Hwang, MD||Kaiser Permanente Fontana Medical Sleep Center|