Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00915499
First received: June 4, 2009
Last updated: February 22, 2013
Last verified: February 2013
  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:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    AHI refers to the number of apneas and hypopneas that occurred per hour of sleep


Secondary Outcome Measures:
  • Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
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
ClinicalTrials.gov Identifier: NCT00915499     History of Changes
Other Study ID Numbers: CA-01-08
Study First Received: June 4, 2009
Results First Received: December 10, 2012
Last Updated: February 22, 2013
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 April 16, 2014