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

• ClinicalTrials.gov Identifier: NCT01462084
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Results First Posted: April 17, 2017
• Last Update Posted: April 17, 2017
• Sponsor: ResMed
• Information provided by (Responsible Party): ResMed

Study Description

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

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea; Central Sleep Apnea (Diagnosis); Chronic Opioid Use	Device: Adaptive servo-ventilation (ASV); Device: Bi-Level PAP	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
• Study Start Date: September 2011
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford Center for Human Sleep Research

Redwood City, California, United States, 94603

Sponsors and Collaborators

ResMed

Investigators

• Principal Investigator: Michelle Cao, DO; Stanford Center for Human Sleep Research

More Information

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT01462084
• Other Study ID Numbers: MA-01-10
• First Posted: October 28, 2011
• Results First Posted: April 17, 2017
• Last Update Posted: April 17, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share IPD with other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by ResMed:

sleeping; opioid medications; positive airway pressure

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases