JMIR Publications

ABSTRACT

Background:

Myofunctional therapy is currently a reasonable therapeutic option to treat obstructive sleep apnea-hypopnea syndrome (OSAHS). This therapy is based on performing regular exercises of the upper airway muscles to increase their tone and prevent their collapse. Over the past decade there has been an increasing number of publications in this area; however, to our knowledge, there are no studies focused on the patients who can most benefit from this therapy.

Objective:

The protocol is for a case-control clinical trial aimed at determining the muscular features of patients recently diagnosed with severe OSAHS compared with healthy controls.

Methods:

Patients meeting set criteria will be sequentially enrolled up to a sample size of 40 patients. Twenty patients who meet the inclusion criteria for controls will also be evaluated. Patients will be examined by a qualified phonoaudiologist who will take biometric measurements and perform the Expanded Protocol of Orofacial Myofunctional Evaluation with Scores (OMES), the Friedman Staging System, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index. Measures of upper airway muscle tone will also be performed using the Iowa Oral Performance Instrument (IOPI) and the tongue digital spoon (TDS) devices. Evaluation will be recorded and reevaluated by a second specialist to determine concordance between observers.

Results:

A total of 60 patients will be enrolled. In the case group of severe OSAHS (40 patients) and the control group will be assessed for differences between upper airway muscle tone and OMES questionnaire.

Conclusions:

This study will help to determine muscle patterns in patients with severe OSAHS and can be used to fill the gap currently present in the assessment of patients suitable to be treated with myofunctional therapy. Clinical Trial: ISRCTN12596010 https://doi.org/10.1186/ISRCTN12596010