Effectiveness of OSA treatment by MAD and CPAP on cardiac autonomic function atdaytime

Not Applicable

• Conditions: G47.31

• Registration Number: DRKS00007772
• Lead Sponsor: Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-06-12
• Study Start: 2015-02-09
• Results First Posted: 2015-10-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

patients with a Obstructive Sleep Apnea (OSA) with an Apnea Hypopnea Index (AHI) > 5 events / hour of sleep (from polysomnograhy)

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>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).