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Sleep Apnea, Obstructive | Upper Airway Toning for Improve the Compliance of CPAP

Sleep Apnea, Obstructive research study

What is the primary objective of this study?

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 donĀ“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.

Who is eligible to participate?

Inclusion Criteria: - Patients with OSA using CPAP Exclusion Criteria: - Neurological Patients

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sleep Apnea, Obstructive

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:CPAPCPAP

Procedure:Upper Airway Toning for Improve the Compliance of CPAPUpper Airway Toning for Improve the Compliance of CPAP

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Control GroupCPAP

EXPERIMENTAL GROUPUpper Airway Toning for Improve the Compliance of CPAP

Study Status

Unknown status

Start Date: June 2013

Completed Date: February 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: CPAP compliance

Secondary Outcome: Sleep Apnea Quality of Life Index (SAQLI) Test

Study sponsors, principal investigator, and references

Principal Investigator: Eduard Estelle

Lead Sponsor: Fisiolistic

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01936038

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