G47.31
Conditions
Interventions
Group 1: Titration and 12 weeks of therapy with a Mandibular Advancement Device (MAD)
Group 2: Titration and 12 weeks of therapy with Continous Positive Airway Pressure (CPAP)
Sponsors
Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - patients with a Obstructive Sleep Apnea (OSA) with an Apnea Hypopnea Index (AHI) > 5 events / hour of sleep (from polysomnograhy)
Exclusion criteria
Exclusion criteria: - participation in a clinical trial up to 4 weeks before entering the study - any presence of sleep disorders other than OSA - any medication intake that could influence the sleep wake rhythm - any kind of specific medication for OSA in the patient’s case history - any psychiatric or neurological diseases previously known or arising during the study that could impair the compliance - occurence of atrial fibrillation - any medication which could affect the heart rate - discontinuation of therapy or interruption of therapy for more than one week - drug abuses - use of any kind of PAP therapy in the past - any pharyngeal surgery (UPPP, LAUP, RFT) for OSA therapy in the past - craniomandibular disorders with restricted mobility of the lower jaw - participants in orthodontic retention for less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The non-invasive parameters of the autonomic nerve system 1) continous finger blood pressure [mmHg], 2) the heart rate variability [msec²], and 3) the barorecptor sensitivity [msec/mmHg] will be determined using a standard 5-minutes test at daytime. The influence of 12 weeks therapy of the obstructive Sleep Apnea (OSA) on these parameters will be analyzed for both treatment arms (time of measurement: before and after 12 weeks of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| By using polysomnography in a sleep lab the degree of respiratory disturbances during sleep (Apnoe Index - AI [1/h], Hypopne Index - HI [1/h], Apnoe Hypopnoe Index - AHI [1/h], Oxygen-Desaturation Index, ODI [1/h]) will be measured. The influence of 12 weeks therapy of the obstructive Sleep Apnea (OSA) on these parameters will be analyzed for both treatment arms (time of measurement: before and after 12 weeks of treatment). | — |
Countries
Germany
Contacts
Public ContactThomas Penzel
Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
Outcome results
None listed