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

NCT00910195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-08-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CPAP treatment with subsequent Bi-Level-APAP treatment

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

Sponsors & Collaborators

  • Wissenschaftliches Institut Bethanien e.V

    lead OTHER

Principal Investigators

  • Wolfgang Galetke, PD Dr.

  • Winfried J. Randerath, Prof. Dr.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00910195 on ClinicalTrials.gov