DRKS00015632.

Study name	Prospective controlled and randomised pilot study of the effect of an intensive orofacial exercise therapy in obstructive sleep apnoea patients.
Methods	Parallel, RCT.
Participants	Inclusion criteria: patients from 18 to 80 years old, with a history of low‐grade or moderate‐grade OSA diagnosed by the history and clinical examination in combination with cardiorespiratory polygraphy; clinical symptoms with bronchopathy (snoring) and/or externally observed respiratory distress and/or daytime fatigue and a polygraphically proven AHI between 10/hour and 30/hour. Exclusion criteria: patients with neurological diseases (especially dementia, Parkinson's disease, multiple sclerosis, state after Apoplex, including all neurodegenerative diseases); patients with a predominantly central form of sleep apnoea; 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); patients with state after uvulopharyngopalatoplasty for the treatment of OSA; patients with state after radiotherapy and / or chemotherapy for malignant tumour of the head and neck; patients under current cPAP or aPAP therapy; pregnancy.
Interventions	Intervention: A specially designed exercise therapy for a period of 6 weeks 3 times a week (Mon‐Wed‐Fri) at the premises of the Speech Therapy Institute / ENT‐University Medical Center Mainz for 35 minutes each. Comparator: Participants in the control group should not perform targeted exercise therapy, but should implement a non‐specific exercise therapy with chewing gum over one hour daily and increased mouth movement while eating for this 6‐week period.
Outcomes	Primary Outcome Measures: Apnea Hypopnea Index. Secondary Outcome Measures: Daytime sleepiness (ESS). Sleep quality (PSQI).
Starting date	Study Start Date: 24 September 2018. Estimated Study Completion Date: not available. Recruitment ongoing.
Contact information	Thomas Brauer. University Medical Center Mainz. Germany.
Notes	Information from DRKS ‐ German Clinical Trials Register.