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Upper Airway Toning for Improve the Compliance of CPAP

NCT ID: NCT01936038

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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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

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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

Conditions

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Sleep Apnea, Obstructive

Keywords

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CPAP Upper Airway Toning Obstructive Sleep Apnoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

CPAP

Group Type PLACEBO_COMPARATOR

CPAP

Intervention Type OTHER

CPAP

EXPERIMENTAL GROUP

Upper Airway Toning for Improve the Compliance of CPAP

Group Type EXPERIMENTAL

CPAP

Intervention Type OTHER

CPAP

Upper Airway Toning for Improve the Compliance of CPAP

Intervention Type PROCEDURE

Upper Airway Toning for Improve the Compliance of CPAP

Interventions

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CPAP

CPAP

Intervention Type OTHER

Upper Airway Toning for Improve the Compliance of CPAP

Upper Airway Toning for Improve the Compliance of CPAP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with OSA using CPAP

Exclusion Criteria

* Neurological Patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisiolistic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduard Estelle

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari General de Catalunya

Anna Bagué

Role: STUDY_CHAIR

Fisiolístic

Xavier Gironés

Role: STUDY_CHAIR

Universitat Internacional de Catalunya

Montserrat Girabent

Role: STUDY_CHAIR

Universitat General de Catalunya

Eduard Estivill

Role: STUDY_CHAIR

Clínica Dexeus

Francesc Segarra

Role: STUDY_CHAIR

Hospital Universitari General de Catalunya

Locations

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Fisiolistic

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Eduard Estelle, Doctor

Role: CONTACT

Phone: 647676131

Email: [email protected]

Facility Contacts

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Anna Maria Bague Cruz, Physio

Role: primary

Other Identifiers

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Upper Airway Toning - 001

Identifier Type: -

Identifier Source: org_study_id