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Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

NCT ID: NCT00915499

Last Updated: 2013-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Complex Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ASV mode

Group Type ACTIVE_COMPARATOR

VPAP Adapt SV

Intervention Type DEVICE

Comparison of ASV and CPAP modes

CPAP mode

Group Type ACTIVE_COMPARATOR

VPAP Adapt SV

Intervention Type DEVICE

Comparison of ASV and CPAP modes

Interventions

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VPAP Adapt SV

Comparison of ASV and CPAP modes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy I Morgenthaler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Sleep Disorders Center

Locations

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REM Medical

Phoenix, Arizona, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

NorthShore University Health System

Skokie, Illinois, United States

Site Status

Mayo Center for Sleep Medicine, Mayo Clinic

Rochester, Minnesota, United States

Site Status

Center for Sleep Medicine

Lafayette Hill, Pennsylvania, United States

Site Status

SleepMed of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24790271 (View on PubMed)

Other Identifiers

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CA-01-08

Identifier Type: -

Identifier Source: org_study_id