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

NCT ID: NCT01462084

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive servo-ventilation (ASV)

Intervention Type: 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 PAP

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Adaptive servo-ventilation (ASV)

Intervention Type: 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 PAP

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Bi-Level PAP

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

Intervention Type: DEVICE

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
• Pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Cao, DO

Role: PRINCIPAL_INVESTIGATOR

Stanford Center for Human Sleep Research

Locations

Stanford Center for Human Sleep Research

Redwood City, California, United States

Countries

United States

Other Identifiers

MA-01-10

Identifier Type: -

Identifier Source: org_study_id