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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SpiroTiger
Sponsored by
Idiag AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, Respiratory Muscle Training, Normocapnic Hyperpnea, SpiroTiger, Polysomnography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wissenschaftliches Institut Bethanien e.V.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respiratory Muscle Training

Arm Description

Outcomes

Primary Outcome Measures

Apnea-hypopnea index, Snoring

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2009
Last Updated
March 9, 2010
Sponsor
Idiag AG
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1. Study Identification

Unique Protocol Identification Number
NCT00936286
Brief Title
Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients
Official Title
The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Idiag AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Obstructive Sleep Apnea Syndrome, Respiratory Muscle Training, Normocapnic Hyperpnea, SpiroTiger, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Respiratory Muscle Training
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SpiroTiger
Other Intervention Name(s)
SpiroTiger Medical
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index, Snoring
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count
Time Frame
5 weeks
Title
Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)
Time Frame
5 weeks
Title
Lung function test parameters (VC, FEV1, MVV, etc.)
Time Frame
5 weeks
Title
Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)
Time Frame
5 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried J. Randerath, Prof. Dr.
Organizational Affiliation
Wissenschaftliches Institut Bethanien e.V
Official's Role
Study Chair
Facility Information:
Facility Name
Wissenschaftliches Institut Bethanien e.V.
City
Solingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42699
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29080065
Citation
Herkenrath SD, Treml M, Priegnitz C, Galetke W, Randerath WJ. Effects of respiratory muscle training (RMT) in patients with mild to moderate obstructive sleep apnea (OSA). Sleep Breath. 2018 May;22(2):323-328. doi: 10.1007/s11325-017-1582-6. Epub 2017 Oct 28.
Results Reference
derived

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

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