Prospective controlled and randomised pilot study of the effect of an intensive orofacial exercise therapy in obstructive sleep apnea patients
- Conditions
- G47.31
- Registration Number
- DRKS00015632
- Lead Sponsor
- niversitätsmedizin Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 40
mild to moderate OSAS: clinical symptoms with rhonchopathy (snoring) and / or externally observed respiratory distress and / or daytime fatigue and a polygraphically proven AHI between 10 / h and 30 / h.
1. Patients <18 years and >80 years
2. Patients with neurological diseases (especially dementia, Parkinson's disease, multiple sclerosis,state after Apoplex, including all neurodegenerative diseases)
3. Patients with a predominantly central form of sleep apnea
4. Patients with state after Palatal, tonsillar, maxillary, mandibular, pharyngeal and laryngeal exacerbations due to a malignancy (state after tonsillotomy or state after tonsillectomy in childhood or adulthood is not an exclusion criterion)
5. Patients with state after Uvulopharyngopalatoplasty for the treatment of obstructive sleep apnea syndrome
6. Patients with state after Radiotherapy and / or chemotherapy for malignant tumors of the head and neck
7. Patients under current cPAP or aPAP therapy
8. Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of the AHI (apnea / hypopnea index) after a specific six-week orofacial logopedic exercise therapy in patients with mild to moderate obstructive sleep apnea syndrome. The measurement takes place before the start of therapy, after the six-week exercise therapy, and at intervals of three months. Therefore we perform and evaluate a cardiorespiratory polygraphic examination with the device Mini Screen plus from Löwenstein medical.
- Secondary Outcome Measures
Name Time Method Reduction in ESS (Epworth Sleepiness Scale) or improvement in PSQI (Pittsburgh Sleep Quality Index) following specific six-week orofacial exercise therapy in patients with mild to moderate obstructive sleep apnea syndrome. Standardized questionnaires are used for this purpose. The questionnaires are answered and evaluated before the start of therapy, directly after the six-week exercise therapy, and after three months.