Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

Study Overview
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Brief Summary
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The main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway)

Detailed Description
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Background: Alternative treatment therapies to positive upper airway pressure (CPAP) for obstructive sleep apnea syndrome (OSAS) have been developed in recent years. Myofunctional orofacial therapy (MFT) is one of these alternatives and consists of exercises that improve mobility and increase muscle strength of the orofacial structures that contribute to the etiopathogenesis of OSAS. To date, any study to treat sleep apnea patients under this therapy has been conducted in Spain. Moreover, its long-term effect has not been evaluated worldwide. Main objective: to compare the reduction in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway) Methodology: A 12-month, randomized, parallel-group, clinical trial will be conducted. Patients with an AHI ≥ 5 events per hour assessed by a respiratory polygraphy (RP) will be randomized to a MFT treatment branch or to another placebo exercises branch. A speech therapist will instruct patients to perform the exercises in both groups for three months. At the end of this period, a RP will be performed on both groups and the same treatment that they were doing will be maintained at home. One year later, a new RP will be performed and changes in AHI, oximetry parameters and snoring will be compared in both groups, as well as sleepiness, quality of life and the degree of adherence to the treatment.

Official Title
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Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea. Randomized Clinical Trial (MYTOSA).

Conditions
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Obstructive Sleep Apnea of Adult, Myofunctional Therapy

Intervention / Treatment
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* Other: Myofunctional Therapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 and under 80 years old. Patients with apnea-hypopnea index from 5 to 29 assessed by a respiratory polygraphy. Absence of daytime sleepiness (Epworth sleepiness scale <12). Exclusion Criteria: Refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic). Ictus, transient ischemic attack, neuromuscular diseases, acute coronary syndrome or hospitalization for worsening heart failure, in the previous 30 days. Professional drivers, profession of risk or respiratory failure. Previous surgical intervention for the treatment of sleep apnea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them,could be included).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms: active treatment group (myofunctional therapy) and placebo group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myofunctional Therapy<br>This therapy consists of the practice of isotonic, isokinetic and isometric exercises that improve mobility and coordination and increase the muscular strength of the orofacial structures that contribute to the obstructive sleep apnea etiopathogenesis. | Other: Myofunctional Therapy<br>* Isometric, isokinetic and isotonic exercises for the upper airway muscles.<br>|
| Placebo Comparator: Placebo<br>The placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway. | Other: Placebo<br>* Exercises that do not alter the function or morphology of the upper airway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI after myofunctional therapy | To compare the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group. | 3 months;12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AIH after 1 year of myofunctional treatment compared to 3 months | To assess whether the change in IAH is maintained comparing 12 months of active home treatment with 3 months of active treatment with a speech pathologist. | 3 months;12 months | 
| Change in snoring | To assess the change in snoring measured by the average intensity in decibels and the number of snoring events per hour. | 3 months;12 months | 
| Change in oximeter parameters | To assess the change in oximeter parameters: percentage of recording time with oxygen saturation < 90% (CT90), oxygen desaturation index (ODI) and mean oxygen saturation | 3 months;12 months | 
| Assessment of the degree of therapeutic adherence at 3,6 and 12 months | To assess the degree of therapeutic adherence to the exercises at 3, 6 and 12 months of treatment. | 3 months; 6 months;12 months | 
| Assessment of generic health-related quality of life | To assess the generic health-related quality of life measured by Short Form-36 Health Survey (SF-36) questionnaire | 3 months;12 months | 
| Assessment of sleep quality | To assess the sleep quality measured by Pittsburgh Quality of Sleep Index questionnaire | 3 months;12 months | 
| Assessment of daytime sleepiness | To assess the change in daytime sleepiness measured by the Epworth sleepiness scale | 3 months;12 months |