Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Detailed description: 
      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
    

Intervention name(s): CPAP treatment with subsequent Bi-Level-APAP treatment; Bi-Level-APAP treatment with subsequent CPAP treatment
Intervention type(s): Device; Device
Intervention description(s): CPAP treatment during the first night and then Bi-level-APAP treatment during second night; Bi-level-APAP treatment during the first night and then CPAP treatment during the second night
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; CPAP; Bi-Level