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Completed

NCT Number: NCT01609244

Bilevel Versus Servoventilation in Complex Sleep Apnea

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

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Key information

Conditions

Complex Sleep Apnea Apnea CPAP Induced Central Sleep Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion criteria

primary central sleep apnea non-compliance to CPAP therapy

Treatment and study plan

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

Primary outcomes

  1. apnea-hypopnea index

    Time frame: at 6 weeks

    apneas and hypopneas under therapy

Secondary outcomes

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

    Time frame: at 6 weeks

    parameters of sleep quality

Sponsors and collaborators

Lead sponsor

Krankenhaus Kloster Grafschaft

Other

Registry information

Acronym: CSA-FKKG

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 31, 2012
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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