Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

ResMed66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Complex Sleep Apnea Syndrome

Interventions

VPAP Adapt SVDEVICE

Comparison of ASV and CPAP modes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

REM Medical

Phoenix, Arizona, United States

Northwestern University

Chicago, Illinois, United States

NorthShore University Health System

Skokie, Illinois, United States

Mayo Center for Sleep Medicine, Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.