Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing
|ClinicalTrials.gov Identifier: NCT00910195|
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : August 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: CPAP treatment with subsequent Bi-Level-APAP treatment Device: Bi-Level-APAP treatment with subsequent CPAP treatment||Not Applicable|
Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnea syndrome patients in our hospital were asked to participate in the study. By a declaration of consent the patients were randomized in two different groups.
Group 1: started with CPAP at the first night and continued with Bi-level- APAP at the second night.
Group 2: began with Bi-level-APAP and ended with CPAP
Patients will be discharged with CPAP after the second night
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: CPAP before Bi-Level-APAP
receiving CPAP treatment during the first night and then Bi-level-APAP treatment during second night
Device: CPAP treatment with subsequent Bi-Level-APAP treatment
CPAP treatment during the first night and then Bi-level-APAP treatment during second night
Experimental: Bi-Level-APAP before CPAP
receiving Bi-level-APAP treatment during the first night and then CPAP treatment during the second night
Device: Bi-Level-APAP treatment with subsequent CPAP treatment
Bi-level-APAP treatment during the first night and then CPAP treatment during the second night
- Obstructive and central apnea-hypopnea-Index. [ Time Frame: day one and two of the study ]
- Total apnea-hypopnea-index, minimum and middle oxygen saturation, subjective satisfaction with the therapy (questionnaire). [ Time Frame: day one and two of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910195
|Wissenschaftliches Institut Bethanien e.V.|
|Solingen, NRW, Germany, 42699|
|Study Chair:||Wolfgang Galetke, PD Dr.|
|Study Director:||Winfried J. Randerath, Prof. Dr.|