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

NCT03670914 | Suspended

• 1 other identifier: WatchPAT200-NARC001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Narcotic Use; Central Sleep Apnea

Keywords

Sleep Disorder Breathing; Central Sleep Apnea; Narcotics; Home Sleep Apnea Testing Device; WatchPAT 200; In-Lab Polysomnography; Comparison; Accuracy; Efficacy

Outcome Measures

Primary Outcomes (2)

• Accuracy of Central Sleep Apnea Events

  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".

  1 year

• Accuracy of Other Various Sleep Metrics

  Compare the efficacy of the WatchPAT200 in detecting narcotic based oxygen, body position, and sleep-wake events to the in-lab polysomnography.

  1 year

Study Arms (1)

WatchPAT 200 and In-Lab Study

EXPERIMENTAL

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

Interventions

WatchPAT 200 DIAGNOSTIC_TEST

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.

WatchPAT 200 and In-Lab Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Sleep Center; San Bernardino County Medical Center, Kaiser Permanente

Fontana, California, 92335, United States

Location

Related Publications (3)

• Chou R, Clark E, Helfand M. Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. J Pain Symptom Manage. 2003 Nov;26(5):1026-48. doi: 10.1016/j.jpainsymman.2003.03.003.

  PMID: 14585554 BACKGROUND

• Sullivan MD, Edlund MJ, Fan MY, DeVries A, Braden JB, Martin BC. Trends in use of opioids for non-cancer pain conditions 2000-2005 in commercial and Medicaid insurance plans: the TROUP study. Pain. 2008 Aug 31;138(2):440-449. doi: 10.1016/j.pain.2008.04.027. Epub 2008 Jun 10.

  PMID: 18547726 BACKGROUND

• Walker JM, Farney RJ, Rhondeau SM, Boyle KM, Valentine K, Cloward TV, Shilling KC. Chronic opioid use is a risk factor for the development of central sleep apnea and ataxic breathing. J Clin Sleep Med. 2007 Aug 15;3(5):455-61.

  PMID: 17803007 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Dennis Hwang, MD

  Kaiser Permanente Fontana Medical Sleep Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Medical Director

Model Details: This is a prospective single cohort study that will evaluate the efficacy of the WatchPAT200 device by comparing it to an in-lab polysomnography.

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: August 8, 2019
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)