Status:
COMPLETED
Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing
Lead Sponsor:
Wissenschaftliches Institut Bethanien e.V
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive cyclic oxygen satura...
Detailed Description
Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnea syndrome patients in our hospital were asked to participate in the study. By a declaration of consent the patie...
Eligibility Criteria
Inclusion
- Men and women \> 18 years.
- Newly diagnosed of sleep-apnea-syndrome, AHI\> 5 per hour associated with the usual manifestation of this syndrome.
- Declaration of consent.
Exclusion
- Absence of declaration of consent.
- Other relevant sleep disorders like insomnia, restless legs, parasomnia
- Heart failure NYHA-CLASS III- IV.
- Myocardial infarction or unstable angina pectoris or cardiac surgery in within the last three months.
- Apnea-hypopnea-index \< 5 per hour.
- Pregnancy.
- Malign diseases.
- Serious chronic oxygen-requiring pulmonary illness.
- Age under 18 years.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00910195
Start Date
June 1 2008
End Date
April 1 2011
Last Update
August 9 2011
Active Locations (1)
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1
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, Germany, 42699