Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- ResMed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Apnea Hypopnea Index (AHI)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Apnea Hypopnea Index (AHI)
Time Frame: 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 Outcomes
- Patient Comfort(Up to 1 month)