Bilevel Versus Servoventilation in Complex Sleep Apnea (CSA-FKKG)

Krankenhaus Kloster Grafschaft

Status: Completed

Conditions: CPAP Induced Central Sleep Apnea; Complex Sleep Apnea

Treatments: Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany); Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT01609244

CSA-2010

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion criteria

primary central sleep apnea non-compliance to CPAP therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Bilevel

Active Comparator group

Description:

Bilevel therapy

Treatment:

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

Servoventilation

Active Comparator group

Description:

servoventilation therapy

Treatment:

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