Clinical trial NCT00915499: Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
Official title: Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Sleep Apnea Syndrome
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2009-06-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: REM Medical
state: Arizona
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Rochester
country: United States
facility: Mayo Center for Sleep Medicine, Mayo Clinic
state: Minnesota
city: Lafayette Hill
country: United States
facility: Center for Sleep Medicine
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: Mayo Sleep Disorders Center
name: Timothy I Morgenthaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgenthaler TI, Kuzniar TJ, Wolfe LF, Willes L, McLain WC 3rd, Goldberg R. The complex sleep apnea resolution study: a prospective randomized controlled trial of continuous positive airway pressure versus adaptive servoventilation therapy. Sleep. 2014 May 1;37(5):927-34. doi: 10.5665/sleep.3662.