Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

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

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)

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea of Adult; Myofunctional Therapy
• Intervention / Treatment: Other: Myofunctional Therapy; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene M Cano Pumarega, PhD, MD; Phone Number: +34 686348243; Email: irene.cano@yahoo.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal, Pneumology Department
    • Contact: Irene M Cano-Pumarega, PhD, MD; Phone Number: +34 686348243; Email: irene.cano@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Myofunctional Therapy; 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; Isometric, isokinetic and isotonic exercises for the upper airway muscles.
PLACEBO_COMPARATOR: Placebo; The placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway.	Other: Placebo; Exercises that do not alter the function or morphology of the upper airway.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: MYTOSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No