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Clinical Trials/NCT00936286
NCT00936286
Completed
Not Applicable

The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients

Idiag AG1 site in 1 country10 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea Syndrome
Sponsor
Idiag AG
Enrollment
10
Locations
1
Primary Endpoint
Apnea-hypopnea index, Snoring
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.

Detailed Description

The obstructive sleep apnea syndrome (OSAS) is of great significance for affected individuals as well as for public health service. Patients suffer from reduced quality of life and show an increased accident risk in road traffic and on the job. Furthermore, OSAS represents an independent risk factor for cardiovascular diseases, in particular arterial hypertension. In sleep apnea patients, the relatively early stimulation of the upper respiratory tract muscles compared to the thoracic respiratory muscles is abrogated in many cases. Alternatively, nerve damage with impaired sensory function in the pharynx area and impaired motor function of the upper air tract musculature, in particular the musculus genioglossus can be observed. The disturbed sensory function impairs the reflex activation of the genioglossus. Moreover, the pattern of neurogenic muscle damage with a loss of the pattern of different types of fibers changed to the point of adjoining atrophic and hypertrophic sections and a more monotonous appearance of fiber types could be detected. During waking hours the activity of the musculus genioglossus is enhanced compared with control persons, which is interpreted as a compensatory mechanism. During sleep time, however, this compensation seems to disappear. In several studies either direct or indirect stimulation of the musculus genioglossus and its supplying nerves were deployed. Yet, the results were inconsistent. The direct muscle stimulation using intramuscular electrodes, although efficient, was no longer pursued due to technical reasons. Although the results of an external stimulation showed improvements regarding apneas and snoring, the findings were usually weakly pronounced. In a study ascertaining muscle training with transcutaneous electrical stimulation a significant improvement regarding snoring was achieved when compared to placebo. In general, no influence on sleep apnea syndrome could be accomplished, although there were individual cases showing a clinically relevant amelioration. A preceding study compared habitual snorers with control persons. It was shown that respiratory muscle training by means of normocapnic hyperpnea was accompanied by enlargement of the musculus genioglossus and reduced snoring. Moreover, an increased physical performance was observed. Thus, the question arises if training of the respiratory musculature by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
March 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Idiag AG

Eligibility Criteria

Inclusion Criteria

  • Mild to intermediate sleep apnea syndrome with AHI of 10 - 30/h and clinical symptoms
  • Refusal of a primary nCPAP therapy
  • Epworth Sleepiness Scale (ESS) score ≥ 9
  • Signed informed consent form

Exclusion Criteria

  • Therapy with pharmaceuticals which can influence the musculature
  • Psychiatric disease which negatively influences compliance
  • Acute and chronic diseases of the lung and/or the respiratory passages
  • BMI ≥ 35 kg/m²

Outcomes

Primary Outcomes

Apnea-hypopnea index, Snoring

Time Frame: 5 weeks

Secondary Outcomes

  • Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count(5 weeks)
  • Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)(5 weeks)
  • Lung function test parameters (VC, FEV1, MVV, etc.)(5 weeks)
  • Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)(5 weeks)

Study Sites (1)

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