N/A
N=66
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
Complex Sleep Apnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00915499 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
Feb 2013
Primary outcome: Primary: Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period — 4.4; 9.9 AHI (events/hour)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VPAP Adapt SV (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period |
4.4; 9.9 | — |
| SECONDARY Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) |
4.6; 4.5; 4.7; 4.6 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00915499). 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.