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

N/ACompletedNCT01462084

ResMed21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Adaptive servo-ventilation (ASV)DEVICE

Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.

Bi-Level PAPDEVICE

Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford Center for Human Sleep Research

Redwood City, California, United States

Outcomes

Primary Outcomes

Apnea Hypopnea Index (AHI)

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).

Time frame: Up to 1 month

Secondary Outcomes

Patient Comfort

Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied

Time frame: Up to 1 month

Data from ClinicalTrials.gov

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