NCT01462084

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-10-28
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study