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

Sponsor:	ResMed
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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 ]

Enrollment:	68
Study Start Date:	May 2009
Study Completion Date:	December 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Locations

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

Sponsors and Collaborators

ResMed

Mayo Clinic

Investigators

Principal Investigator:

Timothy I Morgenthaler, MD

Mayo Sleep Disorders Center

More Information

No publications provided

Responsible Party:	ResMed Corporation
ClinicalTrials.gov Identifier:	NCT00915499 History of Changes
Other Study ID Numbers:	CA-01-08
Study First Received:	June 4, 2009
Last Updated:	January 6, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

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

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012