Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

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.
    

Intervention name(s): SpiroTiger
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): SpiroTiger Medical
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea Syndrome; Respiratory Muscle Training; Normocapnic Hyperpnea; SpiroTiger; Polysomnography