NCT01609244

Brief Summary

Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

May 25, 2012

Last Update Submit

January 6, 2016

Conditions

Complex Sleep ApneaCPAP Induced Central Sleep Apnea

Keywords

Sleep apneacentral sleep apneabilevelservoventilationCPAP

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index

    apneas and hypopneas under therapy

    at 6 weeks

Secondary Outcomes (1)

  • Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy

    at 6 weeks

Study Arms (2)

Bilevel

ACTIVE COMPARATOR

Bilevel therapy

Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)

Servoventilation

ACTIVE COMPARATOR

servoventilation therapy

Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)

Interventions

Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)DEVICE

nighttime positive airway therapy for 6 weeks

Bilevel
servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)DEVICE

nighttime positive airway therapy for 6 weeks

Servoventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

You may not qualify if:

  • primary central sleep apnea non-compliance to CPAP therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

Location

Related Publications (2)

  • Kuzniar TJ, Pusalavidyasagar S, Gay PC, Morgenthaler TI. Natural course of complex sleep apnea--a retrospective study. Sleep Breath. 2008 May;12(2):135-9. doi: 10.1007/s11325-007-0140-z.

    PMID: 17874254BACKGROUND

  • Dellweg D, Kerl J, Hoehn E, Wenzel M, Koehler D. Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea). Sleep. 2013 Aug 1;36(8):1163-71. doi: 10.5665/sleep.2878.

    PMID: 23904676DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Central

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Dominic Dellweg, MD

    FKKG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician sleep laboratoy and home mechanical ventilation unit

Study Record Dates

First Submitted

May 25, 2012

First Posted

May 31, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

DE(1)