Upper Airway Toning for Improve the Compliance of CPAP

September 1, 2013 updated by: Fisiolistic

Effectiveness of Upper Airway Toning as Adjuvant Treatment in the Former Period of Adaptation of the Continuous Positive Airway Pressure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08901
        • Recruiting
        • Fisiolistic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with OSA using CPAP

Exclusion Criteria:

  • Neurological Patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
CPAP
Other: CPAP
CPAP
Experimental: EXPERIMENTAL GROUP
Upper Airway Toning for Improve the Compliance of CPAP
Other: CPAP
CPAP
Procedure: Upper Airway Toning for Improve the Compliance of CPAP
Upper Airway Toning for Improve the Compliance of CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP compliance
Time Frame: 3 months
nominal variable
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Apnea Quality of Life Index (SAQLI) Test
Time Frame: 3 months
Test of quality of life
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisiolistic

Investigators

  • Principal Investigator: Eduard Estelle, Hospital Universitari General de Catalunya
  • Study Chair: Anna Bagué, Fisiolistic
  • Study Chair: Xavier Gironés, Universitat Internacional de Catalunya
  • Study Chair: Montserrat Girabent, Universitat General de Catalunya
  • Study Chair: Eduard Estivill, Clínica Dexeus
  • Study Chair: Francesc Segarra, Hospital Universitari General de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 24, 2013

First Submitted That Met QC Criteria

September 1, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 1, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Upper Airway Toning - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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