Status:
COMPLETED
Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis
Lead Sponsor:
Wissenschaftliches Institut Bethanien e.V
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of...
Detailed Description
Obstructive sleep apnea (OSA) is characterized by repeated occurrence of apneas or reduced inspiratory air flow due to obstructions of the upper airways (hypopneas). These recurring events are accompa...
Eligibility Criteria
Inclusion
- Sleep-related breathing disorders with an apnea-hypopnea index ≥15/h and \<30% central respiratory events (OSA patients)
- Stable optimal medication according to European Society of Cardiology guidelines (if applicable)
Exclusion
- Prior exposure to positive airway pressure treatment
- Atrial fibrillation
- Facial anomalies or injuries inhibiting proper mask fit
- Pregnancy and/or lactation
- Acute life-threatening illness (e.g. instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association stage IV, myocardial infarction, exacerbated Chronic obstructive pulmonary disease, malignant tumor requiring treatment)
- Drug or alcohol abuse
- Intake of hypnotics/sedatives
- Any medical, psychological or other condition impairing the patient's ability to provide informed consent
Key Trial Info
Start Date :
March 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2017
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT01814462
Start Date
March 4 2013
End Date
May 30 2017
Last Update
October 30 2018
Active Locations (1)
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1
Bethanien Hospital
Solingen, Germany, 42699