Prevention of mouth leak by intraoral guard rail with nasal continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea syndrome
Not Applicable
- Conditions
- G47.31
- Registration Number
- DRKS00011103
- Lead Sponsor
- niversitätsklinik für Pneumologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
Patients with already diagnosed OSAS (RDI> 10/h) and an established effective CPAP therapy
- 30-80 years
- Inadequate leakage with respect to the mask specific pressure leakage specifications
- or indication of dry and / or painful dry mucous membranes by the patient under nasal CPAP therapy
Exclusion Criteria
- Medication induced or toxic Induced Sleepless
- Cardiac decompensation with stress insufficiency greater NYHA II
- Neurological or psychiatric pre-existing conditions
- Taking centrally active drugs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proof of preventing leakage mouth with nasal CPAP (Continous Positive Airway Pressure) therapy by an intraoral plate rail in intra-individual comparison with NM (nose mask) and FF (full face mask).The leakage measurement is standardized by the therapy devices. The data is routinely displayed in the recording (Alice5) within the scope of the polysmonography. An algorithm was provided by Respironics for the evaluation.
- Secondary Outcome Measures
Name Time Method Watch activities of the therapy patient acceptability by evaluating extent of mouth leak, necessary therapy pressure, oxygen saturation, sleep quality, patient compliance and the subjective patient satisfaction. For this purpose, a self-generated questionnaire is used with regard to the analogue scales for the assessment of sleep and therapy quality.