Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?

Conditions
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Complex Sleep Apnea Syndrome

Intervention / Treatment
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* Device: VPAP Adapt SV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ASV mode<br> | Device: VPAP Adapt SV<br>* Comparison of ASV and CPAP modes<br>|
| Active Comparator: CPAP mode<br> | Device: VPAP Adapt SV<br>* Comparison of ASV and CPAP modes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | AHI refers to the number of apneas and hypopneas that occurred per hour of sleep | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response. | 3 months |