Complex Sleep Apnea Syndrome (CompSAS) Resolution Study (CompSAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Complex Sleep Apnea Syndrome
• Intervention / Treatment: Device: VPAP Adapt SV

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • REM Medical
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Skokie, Illinois, United States, 60077
      • NorthShore University Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Center for Sleep Medicine, Mayo Clinic
  • Pennsylvania
    • Lafayette Hill, Pennsylvania, United States, 19444
      • Center for Sleep Medicine
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Sleepmed of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ASV mode	Device: VPAP Adapt SV; Comparison of ASV and CPAP modes
ACTIVE_COMPARATOR: CPAP mode	Device: VPAP Adapt SV; Comparison of ASV and CPAP modes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Timothy I Morgenthaler, MD, Mayo Sleep Disorders Center

Publications and helpful links

General Publications

• Morgenthaler TI, Kuzniar TJ, Wolfe LF, Willes L, McLain WC 3rd, Goldberg R. The complex sleep apnea resolution study: a prospective randomized controlled trial of continuous positive airway pressure versus adaptive servoventilation therapy. Sleep. 2014 May 1;37(5):927-34. doi: 10.5665/sleep.3662.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (ESTIMATE): June 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea
• Other Study ID Numbers: CA-01-08