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

ResMed

Status: Completed

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01462084

MA-01-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Adaptive Servo-Ventilation (ASV) then BiLevel PAP

Experimental group

Description:

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.

Treatment:

Device: Bi-Level PAP

Device: Adaptive servo-ventilation (ASV)

Bi-Level PAP then Adaptive Servo-Ventilation (ASV)

Experimental group

Description:

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.

Treatment:

Device: Bi-Level PAP

Device: Adaptive servo-ventilation (ASV)