Clinical trial NCT01936038: Upper Airway Toning for Improve the Compliance of CPAP
Official title: Effectiveness of Upper Airway Toning as Adjuvant Treatment in the Former Period of Adaptation of the Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sleep Apnea, Obstructive
Keywords: CPAP
Upper Airway Toning
Obstructive Sleep Apnoea
Lead sponsor: Fisiolistic
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Patients with OSA using CPAP

Exclusion Criteria:

* Neurological Patients

Primary outcomes:
measure: CPAP compliance
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Apnea Quality of Life Index (SAQLI) Test
timeFrame: 3 months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Fisiolistic
state: Barcelona
Study officials:
affiliation: Hospital Universitari General de Catalunya
name: Eduard Estelle
role: PRINCIPAL_INVESTIGATOR
affiliation: Fisiolístic
name: Anna Bagué
role: STUDY_CHAIR
affiliation: Universitat Internacional de Catalunya
name: Xavier Gironés
role: STUDY_CHAIR
affiliation: Universitat General de Catalunya
name: Montserrat Girabent
role: STUDY_CHAIR
affiliation: Clínica Dexeus
name: Eduard Estivill
role: STUDY_CHAIR
affiliation: Hospital Universitari General de Catalunya
name: Francesc Segarra
role: STUDY_CHAIR
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