Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04169984
• Other study ID #: MYTOSA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: February 2020
• Source: Hospital Universitario Ramon y Cajal
• Contact: Irene M Cano Pumarega, PhD, MD
• Phone: +34 686348243
• Email: irene.cano[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Myofunctional Therapy
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Myofunctional Therapy
Isometric, isokinetic and isotonic exercises for the upper airway muscles.
• Placebo
Exercises that do not alter the function or morphology of the upper airway.

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal, Pneumology Department	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of sleep quality	To assess the sleep quality measured by Pittsburgh Quality of Sleep Index questionnaire	3 months;12 months
Secondary	Assessment of daytime sleepiness	To assess the change in daytime sleepiness measured by the Epworth sleepiness scale	3 months;12 months