Complex Sleep Apnea Syndrome (CompSAS) Resolution Study - Full Text View

Sponsors and Collaborators:	ResMed Mayo Clinic
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00915499

Purpose

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.

Condition	Intervention
Complex Sleep Apnea Syndrome	Device: VPAP Adapt SV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:

To determine if the VPAP Adapt SV device in the ASV mode is superior to fixed PAP (CPAP) in resolving CompSAS over time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess impact of treatment on quality of life; understand which clinical parameters may be associated with CPAP response vs. the requirement for treatment with VPAP Adapt SV [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ASV mode: Active Comparator	Device: VPAP Adapt SV Comparison of ASV and CPAP modes
CPAP mode: Active Comparator	Device: VPAP Adapt SV Comparison of ASV and CPAP modes

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 <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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915499

Contacts

Contact: Eileen Casal, RN, MSN	800-424-0737	eileen.casal@resmed.com
Contact: June Mendoza	800-424-0737	june.mendoza@resmed.com

Locations

United States, Arizona
REM Medical	Not yet recruiting
Phoenix, Arizona, United States, 85037
Contact: Derek Loewy, PhD dloewy@remmedical.com
Principal Investigator: Rochelle Goldberg, MD
United States, Illinois
NorthShore University Health System	Recruiting
Skokie, Illinois, United States, 60077
Contact: Sharon Lariosa, MD slariosa@northshore.org
Principal Investigator: Tomasz Kuzniar, MD
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Helen K Donnelly, RN, BSN, CCRC h-donnelly@northwestern.edu
Principal Investigator: Lisa Woolf, MD
United States, Minnesota
Mayo Sleep Disorder Center, Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nancy Slocumb Slocumb.Nancy@mayo.edu
Principal Investigator: Timothy I Morgenthaler, MD
United States, South Carolina
SleepMed of South Carolina	Recruiting
Columbia, South Carolina, United States, 29201
Contact: Michelle Hardin mhardin@sleepmed.md
Principal Investigator: William C McLain, MD

Sponsors and Collaborators

ResMed

Mayo Clinic

Investigators

Principal Investigator:

Timothy I Morgenthaler, MD

Mayo Sleep Disorder Center

More Information

No publications provided

Responsible Party:	ResMed Corporation ( ResMed Corporation )
Study ID Numbers:	CA-01-08
Study First Received:	June 4, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00915499 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Respiration Disorders
Nervous System Diseases
Dyssomnias
Sleep Disorders

Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 03, 2009