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Complex Sleep Apnea Syndrome (CompSAS) Resolution Study (CompSAS)

Primary Purpose

Complex Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VPAP Adapt SV
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Sleep Apnea Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • REM Medical
  • Northwestern University
  • NorthShore University Health System
  • Mayo Center for Sleep Medicine, Mayo Clinic
  • Center for Sleep Medicine
  • SleepMed of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ASV mode

CPAP mode

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 4, 2009
Last Updated
February 22, 2013
Sponsor
ResMed
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00915499
Brief Title
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
Acronym
CompSAS
Official Title
Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASV mode
Arm Type
Active Comparator
Arm Title
CPAP mode
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
VPAP Adapt SV
Intervention Description
Comparison of ASV and CPAP modes
Primary Outcome Measure Information:
Title
Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
Description
AHI refers to the number of apneas and hypopneas that occurred per hour of sleep
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy I Morgenthaler, MD
Organizational Affiliation
Mayo Sleep Disorders Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
REM Medical
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Mayo Center for Sleep Medicine, Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Center for Sleep Medicine
City
Lafayette Hill
State/Province
Pennsylvania
ZIP/Postal Code
19444
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24790271
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.
Results Reference
derived

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Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

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