Obstructive Sleep Apnea Clinical Trial
Official title:
Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing
Verified date | August 2011 |
Source | Wissenschaftliches Institut Bethanien e.V |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Men and women > 18 years. - Newly diagnosed of sleep-apnea-syndrome, AHI> 5 per hour associated with the usual manifestation of this syndrome. - Declaration of consent. Exclusion Criteria: - Absence of declaration of consent. - Other relevant sleep disorders like insomnia, restless legs, parasomnia - Heart failure NYHA-CLASS III- IV. - Myocardial infarction or unstable angina pectoris or cardiac surgery in within the last three months. - Apnea-hypopnea-index < 5 per hour. - Pregnancy. - Malign diseases. - Serious chronic oxygen-requiring pulmonary illness. - Age under 18 years. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Wissenschaftliches Institut Bethanien e.V. | Solingen | NRW |
Lead Sponsor | Collaborator |
---|---|
Wissenschaftliches Institut Bethanien e.V |
Germany,
Engleman HM, Kingshott RN, Martin SE, Douglas NJ. Cognitive function in the sleep apnea/hypopnea syndrome (SAHS). Sleep. 2000 Jun 15;23 Suppl 4:S102-8. Review. — View Citation
Finn L, Young T, Palta M, Fryback DG. Sleep-disordered breathing and self-reported general health status in the Wisconsin Sleep Cohort Study. Sleep. 1998 Nov 1;21(7):701-6. — View Citation
George CF. Sleep. 5: Driving and automobile crashes in patients with obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Sep;59(9):804-7. Review. — View Citation
Randerath WJ, Galetke W, Ruhle KH. Auto-adjusting CPAP based on impedance versus bilevel pressure in difficult-to-treat sleep apnea syndrome: a prospective randomized crossover study. Med Sci Monit. 2003 Aug;9(8):CR353-8. — View Citation
Randerath WJ, Schraeder O, Galetke W, Feldmeyer F, Rühle KH. Autoadjusting CPAP therapy based on impedance efficacy, compliance and acceptance. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):652-7. — View Citation
Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Nieto FJ, O'Connor GT, Boland LL, Schwartz JE, Samet JM. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med. 2001 Jan;163(1):19-25. — View Citation
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Obstructive and central apnea-hypopnea-Index. | day one and two of the study | No | |
Secondary | Total apnea-hypopnea-index, minimum and middle oxygen saturation, subjective satisfaction with the therapy (questionnaire). | day one and two of the study | No |
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