Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea
Central Sleep Apnea (Diagnosis)
Chronic Opioid Use

Interventions: Device: Adaptive servo-ventilation (ASV)
Device: Bi-Level PAP

Brief Summary: Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications

Detailed Description: The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.

Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.

Recruitment & Eligibility

Inclusion Criteria

At least 18 years old
Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
Using bi-level PAP for at least 30 days

Exclusion Criteria

Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
Narcolepsy
Acute upper respiratory tract infection
Pregnant

Arm && Interventions

Group	Intervention	Description
Adaptive Servo-Ventilation (ASV) then BiLevel PAP	Bi-Level PAP	Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)	Adaptive servo-ventilation (ASV)	Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
Adaptive Servo-Ventilation (ASV) then BiLevel PAP	Adaptive servo-ventilation (ASV)	Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)	Bi-Level PAP	Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	Up to 1 month	Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).

Secondary Outcome Measures

Name	Time	Method
Patient Comfort	Up to 1 month	Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied