Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

Study Overview
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Brief Summary
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To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

Detailed Description
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The use of continuous positive airway pressure (CPAP) with a nasal mask during sleep is the gold standard treatment for moderate to severe obstructive sleep apnea (OSA). However, low adherence to CPAP is the main limiting factor in clinical practice. Recent studies suggest that unintentional air leak through the mouth contributes significantly to poor adherence to CPAP. Orofacial myofunctional therapy (OMT) is effective for treating mild to moderate OSA and has not been tested in patients with mouth air leaks. OSA patients using nasal CPAP and mouth air leaks will be recruited and will use the standard CPAP model and nasal mask during the first and last week of the study to record adherence and home leak. Patients will be treated by performing daily (3 times a day) orofacial myofunctional exercises aimed at strengthening the muscles of the oral cavity. Exercises will be supervised weekly for 3 months. All patients will undergo at the beginning and end of treatment: polysomnography with CPAP and nasal mask, speech-language pathology assessment adequated for OSA (scores ranging from 0 to 241, with higher values indicating greater dysfunction), quality of life questionnaire, and nasosinusal symptoms (SNOT -22), sleep quality (Pittsburgh) and sleepiness (Epworth). Polysomnography will include a pneumotachograph (Hans Rudolph) in the CPAP circuit to record flow and a magnetic jaw movement sensor (Brizzy) to record the episodes of mouth opening. The mouth air leak episodes were considered when they exceeded 20% above baseline (intentional leak with the mask fitted and mouth closed at the beginning of the PSG examination with CPAP) for a minimum of 10 seconds. Leaks ending with arousal or full awakening were considered arousal or full awakening associated with mouth air leak. Mouth opening during the leak episodes was determined by the difference between the amplitude at the end of the leak and the amplitude during the leak. Our hypothesis is that the orofacial myofunctional therapy will reduce mouth leakage in OSA patients treated with CPAP and nasal mask.

Official Title
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Effect of Orofacial Myofunctional Therapy on Unintentional Air Leak From the Oral Cavity in Patients With Obstructive Sleep Apnea Treated With Continuous Positive Upper Airway Pressure (CPAP)

Conditions
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OSA, Apnea+Hypopnea

Intervention / Treatment
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* Behavioral: Orofacial exercises and oropharyngeal functions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Diagnosis of OSA (AHI>15 events/h) on use of CPAP (>3 months) with suspect mouth leak as observed by the complaint of morning dry mouth and or CPAP report indicating an excessive air leak Exclusion Criteria: Central Sleep Apnea, oxygen dependent, COPD.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orofacial exercises and oropharyngeal functions<br>Orofacial exercises and oropharyngeal functions. | Behavioral: Orofacial exercises and oropharyngeal functions<br>* Oropharyngeal exercises (derived from speech-language pathology) to the tongue and facial muscles exercises as well stomatognathic functions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Orofacial Myofunctional Therapy on mouth air leak | The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Orofacial Myofunctional Therapy on the leak in CPAP report | Effect of Orofacial Myofunctional Therapy on the mean value of leak in liters per minute in the CPAP report | 3 months | 
| Effect of Orofacial Myofunctional Therapy on the adherence to CPAP | Effect of Orofacial Myofunctional Therapy on the mean value of hours of use in the CPAP report | 3 months | 
| Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score | The reduction in questionnaire scores on Pittsburgh Sleep Quality Index, ranging from 0 to 21 (referred to as the global score), with the higher total score indicating worse sleep quality, post-Orofacial Myofunctional Therapy | 3 months | 
| Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score | The reduction in questionnaire scores on the perception of excessive daytime somnolence (Epworth Sleepiness Scale, score ranging from 0 to 24, with a total score ≥10 representing excessive daytime sleepiness) post-Orofacial Myofunctional Therapy | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orofacial Myofunctional Therapy, Oropharyngeal exercises, CPAP, Nasal mask, Air leak, Sleep apnea