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Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)

NCT04438785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-11

Study results available
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Summary

• Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to stop and start repeatedly during sleep. There are several types of sleep apnea, the most common of which is obstructive sleep apnea. This type of apnea occurs when an individual's throat muscles intermittently relax and block the airway during sleep.

The classic treatment for this disease is based on weight loss, and exercise, and the use of a continuous positive airway pressure (CPAP) machine.

Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing. MT is based on daily exercises of the throat muscles in an attempt to strengthen them and facilitate opening of the airway.

Who can participate? Patients diagnosed with severe sleep apnea and aged between 18-75 years.

What does the study involve? Participants will be randomly allocated to either use of the "AirwayGym" smartphone app or no treatment for 3 months. The AirwayGym app provides instructions on how to perform exercises to strengthen the throat muscles and reminds participants to perform the exercises for 20 min per day. Participants will be assessed monthly at the clinic.

What are the possible benefits and risks of participating? Benefits: Curing sleep apnea syndrome. There are no significant risks for participants.

Where is the study run from? Hospital Quirónsalud Marbella (Spain) When is the study starting and how long is it expected to run for? October 2018 to January 2021 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr. Carlos O'Connor Reina, [email protected]

Conditions

  • Obstructive Sleep Apnea-hypopnea Syndrome

Interventions

DEVICE

The intervention consists of myofunctional therapy (MT) using the AirwayGym app.

Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.

Sponsors & Collaborators

  • Quironsalud

    lead OTHER

Principal Investigators

  • JOSE MARIA IGNACIO GARCIA, MD · NEUMOLOGY DEPARMENT HOSPITAL QUIRONSALUD MARBELLA

  • FRANCISCO JESUS GONZALEZ SANCHEZPharm D, Pharm D · RESEARCH UNIT HOSPITAL QUIRONSALUD MARBELLA

  • CARLOS O´CONNOR REINA, MD · OTOLARINGOLOGY DEPARMENT HOSPITAL QUIRONSALUD MARBELLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-09-18
Completion
2020-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438785 on ClinicalTrials.gov