Sleep Apnea Syndromes Clinical Trial
Official title:
BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia,
hypercarbia, and central sleep apnea. The aim of this study was to determine the initial
efficacy of auto servo-ventilation (ASV) and after 3 months of home use.
Methods: This prospective multicenter interventional study recruited chronic pain patients
prescribed ≥100 morphine equivalents for at least 4 months.
Participants: Following full-night polysomnography (PSG) to confirm the presence of
sleep-disordered breathing, patients were randomized to three additional full-night-attended
PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an
initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support
(PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or
without mandatory pressure support.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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