NCT00915499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 22, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

June 4, 2009

Results QC Date

December 10, 2012

Last Update Submit

February 22, 2013

Conditions

Complex Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)

    3 months

Study Arms (2)

ASV mode

ACTIVE COMPARATOR
Device: VPAP Adapt SV

CPAP mode

ACTIVE COMPARATOR
Device: VPAP Adapt SV

Interventions

VPAP Adapt SVDEVICE

Comparison of ASV and CPAP modes

ASV modeCPAP mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of complex sleep apnea syndrome (CompSAS)
  • Naive to PAP therapy
  • Requires CPAP ≤15 cm H2O

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

REM Medical

Phoenix, Arizona, 85037, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System

Skokie, Illinois, 60077, United States

Location

Mayo Center for Sleep Medicine, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Center for Sleep Medicine

Lafayette Hill, Pennsylvania, 19444, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

  • 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.

    PMID: 24790271DERIVED

Results Point of Contact

Title
June Mendoza
Organization
ResMed
june.mendoza@resmed.com
1-800-424-0737

Study Officials

  • Timothy I Morgenthaler, MD

    Mayo Sleep Disorders Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

February 28, 2013

Results First Posted

February 22, 2013

Record last verified: 2013-02

Locations

US(6)