UMIN000035476.

Study name	Myofunctional therapy effective for obstructive sleep apnoea in elderly patients.
Methods	Cross‐over, RCT.
Participants	Inclusion criteria: patients 65 years and older who are attending Geriatrics and General medicine at Osaka University, and who were suspected and diagnosed as OSA. Exclusion criteria: patients with cognitive impairment, those under hyperdialysis, those with more CSA than OSA.
Interventions	Intervention: Exercise using 'Fukimodoshi': a Japanese whistle, which is usually used as a toy for children. Comparators: Exercise using a device for exercise of the tongue, which is used to prevent aspiration pneumonia. Pronouncing vowels, elevation of the mouth muscles, suction movements.
Outcomes	Primary Outcome Measures: Portable sleep monitor. Polysomnography. Perum miRNA. Secondary Outcome Measures: Cognitive function. Motor function. PRD.
Starting date	Study Start Date: 1 February 2019. Estimated Study Completion Date: not available.
Contact information	Kazuhiro Hongyo. Osaka University. Geriatrics and General medicine.
Notes	Information from UMIN‐CTR.

Abbreviations: AHI: Apnea‐Hypopnea Index; BMI: Body Mass Index; CHF: Congestive Heart Failure; COPD: Chronic Obstructive Pulmonary Disease; CPAP: Continuous Positive Airway Pressure; ENT: ear, nose and throat; ESS: Epworth Sleepness Scale; IOPI: Iowa Oral Performance Instrument; ODI: oxygen desaturation index; OSA: Obstructive Sleep Apnea; PAP: positive airway pressure; PSQI: Pittsburgh Sleep Quality Index; PRD: Periodic Repolarization Dynamics; PVT: psychomotor vigilance test; RCT: Randomised Clinical Trial; SaO2: oxygen desaturation; SD: Standard Deviation; SMD: Standardised Mean Difference; SF‐36: 36‐item Short Form health survey; VAS: visual analogue scale; WHOQOL‐BREF: World Health Organization Quality of Life