G47.31
Conditions
Interventions
Group 1: The "somnipax silent sleepy" anti-snoring mouthpiece from Somni Health and Safety is used as shield rail. Study participants will be asked to spend three nights in the sleep laboratory. In a
Sponsors
Universitätsklinik für Pneumologie
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactSebastian Föllner
Universitätsklinik für Pneumologie
Outcome results
None listed