CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 target
Drug / intervention
CPAP treatment with subsequent Bi-Level-APAP treatment +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00910195
NCT00910195N/ACompleted

Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing

Wissenschaftliches Institut Bethanien e.V·interventional·Posted May 29, 2009·Updated Aug 9, 2011

In Brief

A clinical study evaluating CPAP treatment with subsequent Bi-Level-APAP treatment and Bi-Level-APAP treatment with subsequent CPAP treatment for Obstructive Sleep Apnea. Completed, enrolled 150 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2009
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.1 years ago

Interventions

CPAP treatment with subsequent Bi-Level-APAP treatmentdevice

CPAP treatment during the first night and then Bi-level-APAP treatment during second night

Bi-Level-APAP treatment with subsequent CPAP treatmentdevice

Bi-level-APAP treatment during the first night and then CPAP treatment during the second night