Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
This study has been completed.
Sponsor:
ResMed
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
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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 May 23, 2013