Upper Airway Toning for Improve the Compliance of CPAP

Phase 1

• Conditions: Sleep Apnea, Obstructive
• Interventions: Other: CPAP; Procedure: Upper Airway Toning for Improve the Compliance of CPAP

• Registration Number: NCT01936038
• Lead Sponsor: Fisiolistic

Brief 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.

Detailed Description

OBJECTIVES

Main objective: To increase the percentage of Nasal Continuous Positive Airway Pressure (nCPAP) compliance.

Secondary objectives:

* To increase the CPAP's tolerance.

* To decrease the CPAP's pressure.

* To decrease the daytime sleepiness.

* To increase the quality of life related to sleep.

* To assess the level of subjective utility of CPAP by the patient.

METHODOLOGY

Type of study: Controlled randomized simple blind study

Randomization of groups

Once the patient is into the study (because s/he has the inclusion criteria and has signed up the informed consent), an opaque envelope is opened in order to know the assigned group.The envelopes are consecutively numbered and the assigned group is randomized through the software.

* Group 1 or control group: 55 subjects undergo the CPAP treatment.

* Group 2 or study group: 55 subjects undergo the CPAP treatment and Upper Airway Toning.

Homogeneity of groups:

Investigators check out the homogeneity of groups in baseline:

Specific features: Neck circumference, presence or lack of nasal clinic, presence or lack of nasal structural alteration, age, gender, weight, height, BMI, smoking habits.

Polysomnographic parameters: Number of apnea, number of hypo-apneas and Apnea Hypopnea Index (AHI).

Symptoms: Presence or lack of severe comorbidities, level of daily hyper-somnolence, presence of insomnia

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-24
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-01
• Last Update Submitted: 2013-09-01
• Study First Posted: 2013-09-05
• Last Update Posted: 2013-09-05
• Primary Completion: 2013-12
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients with OSA using CPAP

Exclusion Criteria

• Neurological Patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	CPAP	CPAP
EXPERIMENTAL GROUP	CPAP	Upper Airway Toning for Improve the Compliance of CPAP
EXPERIMENTAL GROUP	Upper Airway Toning for Improve the Compliance of CPAP	Upper Airway Toning for Improve the Compliance of CPAP

Primary Outcome Measures

Name	Time	Method
CPAP compliance	3 months	nominal variable

Secondary Outcome Measures

Name	Time	Method
Sleep Apnea Quality of Life Index (SAQLI) Test	3 months	Test of quality of life

Trial Locations

Locations (1)

Fisiolistic; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain