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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2012

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Adaptive Servo-Ventilation (ASV) then BiLevel 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.
  • Experimental: Bi-Level PAP then 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michelle Cao, DO, Principal Investigator, Stanford Center for Human Sleep Research

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