Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

NCT04169984 | Unknown DMC

• 1 other identifier: MYTOSA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Obstructive Sleep Apnea of Adult; Myofunctional Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in AIH after 1 year of myofunctional treatment compared to 3 months

  3 months;12 months

• Change in snoring

  3 months;12 months

• Change in oximeter parameters

  3 months;12 months

• Assessment of the degree of therapeutic adherence at 3,6 and 12 months

  3 months; 6 months;12 months

• Assessment of generic health-related quality of life

  3 months;12 months

Study Arms (2)

Myofunctional Therapy

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Myofunctional Therapy OTHER

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

Myofunctional Therapy

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal, Pneumology Department

Madrid, 28034, Spain

Location

MeSH Terms

Interventions

Myofunctional Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Central Study Contacts

Irene M Cano Pumarega, PhD, MD

CONTACT

+34 686348243; irene.cano@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arms: active treatment group (myofunctional therapy) and placebo group

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 20, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)