Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

NCT ID: NCT04169984

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-06-30

Brief Summary

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

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.

Conditions

Obstructive Sleep Apnea of Adult; Myofunctional Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Myofunctional Therapy

Intervention Type: OTHER

Isometric, isokinetic and isotonic exercises for the upper airway muscles.

Placebo

The placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Exercises that do not alter the function or morphology of the upper airway.

Interventions

Myofunctional Therapy

Isometric, isokinetic and isotonic exercises for the upper airway muscles.

Intervention Type: OTHER

Placebo

Exercises that do not alter the function or morphology of the upper airway.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Irene Cano-Pumarega

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Ramón y Cajal, Pneumology Department

Madrid, , Spain

Countries

Spain

Central Contacts

Irene M Cano Pumarega, PhD, MD

Role: CONTACT

irene.cano@yahoo.com

+34 686348243

Facility Contacts

Irene M Cano-Pumarega, PhD, MD

Role: primary

irene.cano@yahoo.com

+34 686348243

Other Identifiers

MYTOSA

Identifier Type: -

Identifier Source: org_study_id