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

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ClinicalTrials.gov Identifier: NCT00915499
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : February 22, 2013
Last Update Posted : February 28, 2013
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Complex Sleep Apnea Syndrome Device: VPAP Adapt SV Not Applicable

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  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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?
Study Start Date : May 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period [ Time Frame: 3 months ]
    AHI refers to the number of apneas and hypopneas that occurred per hour of sleep


Secondary Outcome Measures :
  1. Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00915499     History of Changes
Other Study ID Numbers: CA-01-08
First Posted: June 8, 2009    Key Record Dates
Results First Posted: February 22, 2013
Last Update Posted: February 28, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases