CClinicalTrials.gg
Status unknownNCT01936038Updated Sep 5, 2013

Upper Airway Toning for Improve the Compliance of CPAP

A Phase 1 interventional study of CPAP and Upper Airway Toning for Improve the Compliance of CPAP in Sleep Apnea, Obstructive, sponsored by Fisiolistic. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by Fisiolistic · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Sleep Apnea, Obstructive

Keywords

  • CPAP
  • Upper Airway Toning
  • Obstructive Sleep Apnoea
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 110 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

This is the only study on the registry with Fisiolistic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with OSA using CPAP

Exclusion criteria

Exclusion Criteria:

  • Neurological Patients
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Placebo comparator
    Control Group

    CPAP

    Other: CPAP

  • Experimental
    EXPERIMENTAL GROUP

    Upper Airway Toning for Improve the Compliance of CPAP

    Other: CPAP · Procedure: Upper Airway Toning for Improve the Compliance of CPAP

Interventions

  • OtherCPAP

    CPAP

  • ProcedureUpper Airway Toning for Improve the Compliance of CPAP

    Upper Airway Toning for Improve the Compliance of CPAP

06

What researchers measure

Primary outcomes

  1. CPAP compliance

    nominal variable

    Time frame: 3 months

Secondary outcomes

  1. Sleep Apnea Quality of Life Index (SAQLI) Test

    Test of quality of life

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Fisiolistic
    Hospitalet de Llobregat, Barcelona 08901, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01936038
Lead sponsor
Fisiolistic
Responsible party
Sponsor
First posted
Sep 5, 2013
Start date
Jun 2013
Primary completion
Dec 2013 (estimated)
Completion
Feb 2014 (estimated)
Last update
Sep 5, 2013

Study contacts

Eduard Estelle, Doctor
Contact
annabague@hotmail.com
647676131
Eduard Estelle
principal investigator · Hospital Universitari General de Catalunya
Anna Bagué
study chair · Fisiolístic
Xavier Gironés
study chair · Universitat Internacional de Catalunya
Montserrat Girabent
study chair · Universitat General de Catalunya
Eduard Estivill
study chair · Clínica Dexeus
Francesc Segarra
study chair · Hospital Universitari General de Catalunya

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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