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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 10, 2010
March 1, 2010
1 year
July 7, 2009
March 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea index, Snoring
5 weeks
Secondary Outcomes (4)
Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count
5 weeks
Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)
5 weeks
Lung function test parameters (VC, FEV1, MVV, etc.)
5 weeks
Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)
5 weeks
Study Arms (1)
Respiratory Muscle Training
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Idiag AGlead
Study Sites (1)
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, 42699, Germany
Related Publications (1)
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.
PMID: 29080065DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Winfried J. Randerath, Prof. Dr.
Wissenschaftliches Institut Bethanien e.V
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 10, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
March 1, 2010
Last Updated
March 10, 2010
Record last verified: 2010-03