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Completed

NCT Number: NCT00936286

Respiratory Muscle Training in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpiroTiger

Device

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 names: SpiroTiger Medical

Primary outcomes

  1. Apnea-hypopnea index, Snoring

    Time frame: 5 weeks

Secondary outcomes

  1. Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count

    Time frame: 5 weeks

  2. Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)

    Time frame: 5 weeks

  3. Lung function test parameters (VC, FEV1, MVV, etc.)

    Time frame: 5 weeks

  4. Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Idiag AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 10, 2009
Registry last updated
Mar 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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