Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007772

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients who suffer from frequent breathing cessations during the night, called obstructive sleep apnea (OSA), do have an increased risk for heart circulatory diseases, e.g. high blood pressure. An elevated state of the autonomic nerve system (ANS) mirrors these increased risk and could be measured by non-invasive methods.
The aim of this study is to investigate in patients with a need to treat their OSA the beneficial effect of a therapy with a mandibular advancement device (MAD) in comparison with a continuous airway pressure (CPAP) therapy on the heart circulatory system by investigating certain ANS measures at daytime.
In addition the efficacy of both, MAD and CPAP, on the on the abolishment of breathing cessations should be demonstrated.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Obstructive Sleep Apnea (OSA) is the most common type of sleep disordered breathing which affects about 5-7 % of adult population. Repetitive collapses of the upper airways during sleep lead to hypoxic phases with associated sleep fragmentation and sympathetic activation, the latter also persisting during daytime with corresponding consequences. Thus OSA was verified to be an independent cardiovascular risk factor and can increase mortality if not being treated.
Beside the investigation of blood pressure (BP) the measurement or heart rate variability (HRV) and baroreceptor sensitivity (BRS) depicts a non-invasive method to assess autonomic activity. In OSA patients the regular use of continuous positive pressure (CPAP) therapy improves these parameters during night and daytime as a sign for a reduction of a sympathetic over activation. Unfortunately many patients demonstrate limited adherence to CPAP therapy. Therefore there is a need for alternative therapeutic approaches being as effective as CPAP therapy concerning not only symptoms but also cardiovascular consequences of OSA. Intraoral mandibular advancement devices (MAD) protrude the mandible during sleep and should maintain upper airways patency and therefore might be an alternative approach to CPAP.
The present study aimed to evaluate the efficacy of MAD and CPAP with regard to cardiovascular parameters and autonomic activity in a two-period crossover design were n=40 OSA patients are randomized either to sequence MAD-CPAP (12 weeks MAD followed by 12 weeks CPAP) or sequence CPAP-MAD (3 month CPAP followed by 3 month MAD). Main parameters are the daytime continuous BP, HRV, and BRS whereas secondary parameters are the number of breathing cessations (Apnea Index - AI, Hypopnea-Index - HI, Apnea Hypopnea Index - AHI, Oxygen-Desaturation Index, ODI) during the night.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007772
  •   2015/02/09
  •   [---]*
  •   yes
  •   Approved
  •   EA1/282/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G47.31 -  [generalization G47.3: Sleep apnoea]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Titration and 12 weeks of therapy with a Mandibular Advancement Device (MAD)
  •   Titration and 12 weeks of therapy with Continous Positive Airway Pressure (CPAP)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/08/17
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Mr.  Prof. Dr.   Ingo  Fietze 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Mr.  Prof. Dr.  Thomas  Penzel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • SomnoMed Europe AG
    • Kreuzstrasse 54
    • CH-8032  Zürich
    • Switzerland
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/06/12
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.