Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Complex Sleep Apnea Syndrome
- Sponsor
- ResMed
- Enrollment
- 66
- Locations
- 6
- Primary Endpoint
- Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
Detailed Description
Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of complex sleep apnea syndrome (CompSAS)
- •Naive to PAP therapy
- •Requires CPAP ≤15 cm H2O
Exclusion Criteria
- •Requires supplemental oxygen or with a baseline SaO2 \<90%
- •Requires CPAP \> 15 cm H2O
- •Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure
- •Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
Outcomes
Primary Outcomes
Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
Time Frame: 3 months
AHI refers to the number of apneas and hypopneas that occurred per hour of sleep
Secondary Outcomes
- Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)(3 months)