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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
History of Changes
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Syndrome
 Device: SpiroTiger

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Idiag AG:

Primary Outcome Measures:
  • Apnea-hypopnea index, Snoring [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Respiratory Muscle Training 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936286

Locations
Germany
Wissenschaftliches Institut Bethanien e.V.
Solingen, Nordrhein-Westfalen, Germany, 42699
Sponsors and Collaborators
Idiag AG
Investigators
Study Chair: Winfried J. Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Winfried J. Randerath, Wissenschaftliches Institut Bethanien e.V.
ClinicalTrials.gov Identifier: NCT00936286     History of Changes
Other Study ID Numbers: WI_SpiroTiger_87/2008
Study First Received: July 7, 2009
Last Updated: March 9, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Idiag AG:
Obstructive Sleep Apnea Syndrome
Respiratory Muscle Training
Normocapnic Hyperpnea
SpiroTiger
Polysomnography

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013