Bilevel Versus Servoventilation in Complex Sleep Apnea

NCT ID: NCT01609244

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.

Conditions

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Complex Sleep Apnea CPAP Induced Central Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bilevel

Bilevel therapy

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

nighttime positive airway therapy for 6 weeks

Servoventilation

servoventilation therapy

Group Type ACTIVE_COMPARATOR

servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)

Intervention Type DEVICE

nighttime positive airway therapy for 6 weeks

Interventions

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

nighttime positive airway therapy for 6 weeks

Intervention Type DEVICE

servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)

nighttime positive airway therapy for 6 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria

primary central sleep apnea non-compliance to CPAP therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Kloster Grafschaft

OTHER

Sponsor Role lead

Responsible Party

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Dominic Dellweg, M.D.

Attending physician sleep laboratoy and home mechanical ventilation unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominic Dellweg, MD

Role: STUDY_CHAIR

FKKG

Locations

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Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17874254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23904676 (View on PubMed)

Other Identifiers

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CSA-2010

Identifier Type: -

Identifier Source: org_study_id

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