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

This study has been completed.
Sponsor:
Information provided by:
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT00910195
First received: May 28, 2009
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention
Obstructive Sleep Apnea
Device: CPAP treatment with subsequent Bi-Level-APAP treatment
Device: Bi-Level-APAP treatment with subsequent CPAP treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing

Resource links provided by NLM:


Further study details as provided by Wissenschaftliches Institut Bethanien e.V:

Primary Outcome Measures:
  • Obstructive and central apnea-hypopnea-Index. [ Time Frame: day one and two of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total apnea-hypopnea-index, minimum and middle oxygen saturation, subjective satisfaction with the therapy (questionnaire). [ Time Frame: day one and two of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910195

Locations
Germany
Wissenschaftliches Institut Bethanien e.V.
Solingen, NRW, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Investigators
Study Chair: Wolfgang Galetke, PD Dr.
Study Director: Winfried J. Randerath, Prof. Dr.
  More Information

Publications:
Responsible Party: Prof. Dr. Randerath, Institut für Pneumologie an der Universität Witten/Herdecke
ClinicalTrials.gov Identifier: NCT00910195     History of Changes
Other Study ID Numbers: WI_BiLevel APAP_34/2008
Study First Received: May 28, 2009
Last Updated: August 8, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Obstructive sleep apnea
CPAP
Bi-Level

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 14, 2014