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

August 8, 2011 updated by: Wissenschaftliches Institut Bethanien e.V

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Solingen, NRW, Germany, 42699
        • Wissenschaftliches Institut Bethanien e.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Obstructive and central apnea-hypopnea-Index.
Time Frame: day one and two of the study
day one and two of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Total apnea-hypopnea-index, minimum and middle oxygen saturation, subjective satisfaction with the therapy (questionnaire).
Time Frame: day one and two of the study
day one and two of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wissenschaftliches Institut Bethanien e.V

Investigators

  • Study Chair: Wolfgang Galetke, PD Dr.
  • Study Director: Winfried J. Randerath, Prof. Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (ESTIMATE)

May 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI_BiLevel APAP_34/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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