Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

Complex Sleep Apnea Syndrome Clinical Trial

— CompSAS  

Official title:

Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915499
• Other study ID #: CA-01-08
• Status: Completed
• Phase: N/A
• First received: June 4, 2009
• Last updated: February 22, 2013
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Complex Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Device:
• VPAP Adapt SV
Comparison of ASV and CPAP modes

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Center for Sleep Medicine	Lafayette Hill	Pennsylvania
United States	REM Medical	Phoenix	Arizona
United States	Mayo Center for Sleep Medicine, Mayo Clinic	Rochester	Minnesota
United States	NorthShore University Health System	Skokie	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period	AHI refers to the number of apneas and hypopneas that occurred per hour of sleep	3 months	No
Secondary	Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)	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.	3 months	No