Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

Not Applicable

Completed

• Conditions: Complex Sleep Apnea Syndrome
• Interventions: Device: VPAP Adapt SV

• Registration Number: NCT00915499
• Lead Sponsor: ResMed

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Results First Submitted: 2012-12-10
• Results First Submitted QC: 2013-01-18
• Status Verified: 2013-02
• Results First Posted: 2013-02-22
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASV mode	VPAP Adapt SV	-
CPAP mode	VPAP Adapt SV	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)	3 months	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.

Trial Locations

Locations (6)

REM Medical; 🇺🇸 Phoenix, Arizona, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Mayo Center for Sleep Medicine, Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States

NorthShore University Health System; 🇺🇸 Skokie, Illinois, United States

Center for Sleep Medicine; 🇺🇸 Lafayette Hill, Pennsylvania, United States