Status:
COMPLETED
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
Lead Sponsor:
ResMed
Collaborating Sponsors:
Mayo Clinic
Conditions:
Complex Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 respirato...
Eligibility Criteria
Inclusion
- Diagnosis of complex sleep apnea syndrome (CompSAS)
- Naive to PAP therapy
- Requires CPAP ≤15 cm H2O
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00915499
Start Date
May 1 2009
End Date
December 1 2011
Last Update
February 28 2013
Active Locations (6)
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1
REM Medical
Phoenix, Arizona, United States, 85037
2
Northwestern University
Chicago, Illinois, United States, 60611
3
NorthShore University Health System
Skokie, Illinois, United States, 60077
4
Mayo Center for Sleep Medicine, Mayo Clinic
Rochester, Minnesota, United States, 55905