N/A
Completed N=21
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
Source: ClinicalTrials.gov NCT01462084 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Apnea Hypopnea Index (AHI) — 2.5; 16.3 events/hour
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
2.5; 16.3 | — |
| SECONDARY Patient Comfort |
76.0; 67.8 | — |
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
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. Informational only — not medical advice.