Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients

This study has been completed.
Sponsor:
Information provided by:
Idiag AG
ClinicalTrials.gov Identifier:
NCT00936286
First received: July 7, 2009
Last updated: March 9, 2010
Last verified: March 2010

July 7, 2009
March 9, 2010
January 2009
January 2010   (final data collection date for primary outcome measure)
Apnea-hypopnea index, Snoring [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00936286 on ClinicalTrials.gov Archive Site
  • Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Lung function test parameters (VC, FEV1, MVV, etc.) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients
The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
Device: SpiroTiger
Respiratory muscle training with SpiroTiger device, 1 week training initiation and 4 weeks training period with 5 training days per week, training duration 30 min each. Respiratory bag volume set at 50% VC, respiratory frequency starting from 50% MVV. Weekly control trainings.
Other Name: SpiroTiger Medical
Experimental: Respiratory Muscle Training
Intervention: Device: SpiroTiger
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00936286
WI_SpiroTiger_87/2008
No
Prof. Dr. med. Winfried J. Randerath, Wissenschaftliches Institut Bethanien e.V.
Idiag AG
Not Provided
Study Chair: Winfried J. Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V
Idiag AG
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP