Bilevel Versus Servoventilation in Complex Sleep Apnea

Krankenhaus Kloster Grafschaft30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Complex Sleep Apnea CPAP Induced Central Sleep Apnea

Interventions

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

nighttime positive airway therapy for 6 weeks

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

nighttime positive airway therapy for 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment Exclusion Criteria: primary central sleep apnea non-compliance to CPAP therapy

Locations (1)

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

apnea-hypopnea index

apneas and hypopneas under therapy

Time frame: at 6 weeks

Secondary Outcomes

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

parameters of sleep quality

Time frame: at 6 weeks

Data from ClinicalTrials.gov

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