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Prospective controlled and randomised pilot study of the effect of an intensive orofacial exercise therapy in obstructive sleep apnea patients

Prospective controlled and randomised pilot study of the effect of an intensive orofacial exercise therapy in obstructive sleep apnea patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015632
Enrollment
40
Registered
2018-09-25
Start date
2018-09-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.31

Interventions

Group 1: Patients with a history of low-grade or moderate-grade OSAS (Obstructive Sleep Apnea Syndrome) diagnosed by the history and clinical examination in combination with cardiorespiratory polygrap
otherwise the patients of the control group will keep an exercise diary.

Sponsors

Universitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Patients 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactHaralampos Gouveris

Hals-, Nasen,- Ohrenklinik und Poliklinik, Universitätsmedizin Mainz

haralampos.gouveris@unimedizin-mainz.de06131/172664

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026