Upper Airway Toning for Improve the Compliance of CPAP

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936038
• Other study ID #: Upper Airway Toning - 001
• Status: Recruiting
• Phase: Phase 1
• First received: August 24, 2013
• Last updated: September 1, 2013
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: Fisiolistic
• Contact: Eduard Estelle, Doctor
• Phone: 647676131
• Email: annabague[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with OSA using CPAP

Exclusion Criteria:

• Neurological Patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Other:
• CPAP
CPAP

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

Locations

Country	Name	City	State
Spain	Fisiolistic	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fisiolistic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP compliance	nominal variable	3 months	Yes
Secondary	Sleep Apnea Quality of Life Index (SAQLI) Test	Test of quality of life	3 months	Yes