|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00936286 |
|
Date of registration:
|
07/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients
|
|
Scientific title:
|
The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00936286 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Winfried J. Randerath, Prof. Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wissenschaftliches Institut Bethanien e.V |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Obstructive Sleep Apnea Syndrome
|
|
Intervention(s)
|
|
Device: SpiroTiger
|
|
Primary Outcome(s)
|
|
Apnea-hypopnea index, Snoring
[Time Frame: 5 weeks]
|
|
Secondary Outcome(s)
|
|
Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)
[Time Frame: 5 weeks]
|
|
Lung function test parameters (VC, FEV1, MVV, etc.)
[Time Frame: 5 weeks]
|
|
Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)
[Time Frame: 5 weeks]
|
|
Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count
[Time Frame: 5 weeks]
|
|
Secondary ID(s)
|
|
WI_SpiroTiger_87/2008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|