This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Obstructive Sleep Apnea
and you are
between 18 and 80
years old
-
The phase for this study is not defined.
Show me locations

The purpose

Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive cyclic oxygen saturation, as a result from sleep fragmentation related to the arousals in sleeping profile and clinical consequences like day drowsiness, neuropsychological deficits, raised danger of accidents and cardiovascular disease. (1-6). The therapy of choice is the application of nasal continuous positive airway pressure (CPAP) (7-9). Increasing relevance obtain the combined sleep-related breathing disturbances, where the patient shows an obstructive sleep apnea syndrome and some central breathing disturbances in the polysomnography at night. Those patients frequently present with cardiovascular diseases. These combined night breathing disturbances are frequently insufficient to be mitigated exclusively with a CPAP therapy. Some modifications of nCPAP therapy were developed in order to optimize the therapy-compliance and the effectiveness of the therapy. Bi-level-CPAP-devices produce two pressure levels: one for inspiration and another for expiration, so that the patients are able expire against a constant low pressure. An increase in the use of this application in comparison between the conventional or the automatic CPAP therapy could not be proved in early studies. (12, 13) The principle of the automatic nCPAP therapy is to recognize the patient's current need of pressure and to alter the pressure within a set range by applying different algorithms. Some studies have shown that this therapy increased compliance and comfort (14-16), while other studies could not confirm these results. (17, 18) The result of the current study should prove if the treatment of a new algorithm therapy based on an automatic bi-level-system for patients with sleep-related respiratory disorders is as effectively and subjective more comfortable as the conventional CPAP therapy. Patients with a particularly high need of pressure should experience a clear expiratory pressure relief and a higher comfort. Therefore a better compliance is to expect. In the same way patients with additional central respiratory disturbances should obtain a benefit from the bi-level modus. This new treatment would help particularly such "critical patients", who are not responding well to the CPAP therapy or find it uncomfortable.

Provided treatments

  • Device: CPAP treatment with subsequent Bi-Level-APAP treatment
  • Device: Bi-Level-APAP treatment with subsequent CPAP treatment
Tris trial is registered with FDA with number: NCT00910195. The sponsor of the trial is Wissenschaftliches Institut Bethanien e.V and it is looking for 150 volunteers for the current phase.
Official trial title:
Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing