N/A N=21 Randomized Triple-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01462084 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Apnea Hypopnea Index (AHI) — 2.5; 16.3 events/hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Adaptive servo-ventilation (ASV) (Device); Bi-Level PAP (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ResMed
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Apnea Hypopnea Index (AHI)	2.5; 16.3	—
SECONDARY Patient Comfort	76.0; 67.8	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01462084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.