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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
continuous positive airway pressure
servo ventilation titrated in manual mode
Sleep D/O Center of Alabama
Birmingham, Alabama, United States
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Number of Sleep Related Events Per Hour
The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
Time frame: four full night Polysomnography (PSG's)
Percent Oxygen Saturation
Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.
Time frame: four full night Polysomnography (PSG's)
Number of Arterial Oxygen Saturation Per Hour
Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.
Time frame: four full night Polysomnography (PSG's)
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