Upper Airway Toning for Improve the Compliance of CPAP

Summary

The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens at night and consists of the interruption of airflow for more than five seconds. His current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and therefore the level of compliance is key to patient improvement. Many patients don´t tolerate CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These techniques are: oropharyngeal exercises executed actively by the patient for the muscle toning of the upper airways, electrostimulation of the muscles in the floor of the mouth, correction of the tongue position, nasal and bronchial fogging, execution of respiratory gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical column,and massage in the diaphragm. All the techniques together seek for a greater or lesser impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal reflux, the excessive accumulation of secretions in the upper and lower airways, the obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All these disfunctions will make easier for the patient to show side effects in the use of CPAP. There will be a double-blind randomized controlled study with 110 individuals. One group will follow the conventional medical treatment with CPAP and the other group medical treatment plus Upper Airway Toning. After six months, the mean improvement between the two groups will be compared.

Conditions

• Sleep Apnea, Obstructive

Interventions

OTHER

CPAP

CPAP

PROCEDURE

Upper Airway Toning for Improve the Compliance of CPAP

Upper Airway Toning for Improve the Compliance of CPAP

Sponsors & Collaborators

• Fisiolistic

  lead OTHER

Principal Investigators

• Eduard Estelle · Hospital Universitari General de Catalunya

• Anna Bagué · Fisiolístic

• Xavier Gironés · Universitat Internacional de Catalunya

• Montserrat Girabent · Universitat General de Catalunya

• Eduard Estivill · Clínica Dexeus

• Francesc Segarra · Hospital Universitari General de Catalunya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2013-12-31

Completion

2014-02-28

Countries

• Spain

Study Locations