Central Sleep Apnea Clinical Trial
— WP-NARC001Official title:
Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications
Verified date | July 2022 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Suspended |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Sleep Center; San Bernardino County Medical Center, Kaiser Permanente | Fontana | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
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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. Erratum in: J Clin Sleep Med. 2007 Oct 15;3(6):table of contents. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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