NCT01936038

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

August 24, 2013

Last Update Submit

September 1, 2013

Conditions

Sleep Apnea, Obstructive

Keywords

CPAPUpper Airway ToningObstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

  • CPAP compliance

    nominal variable

    3 months

Secondary Outcomes (1)

  • Sleep Apnea Quality of Life Index (SAQLI) Test

    3 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

CPAP

Other: CPAP

EXPERIMENTAL GROUP

EXPERIMENTAL

Upper Airway Toning for Improve the Compliance of CPAP

Other: CPAPProcedure: Upper Airway Toning for Improve the Compliance of CPAP

Interventions

CPAPOTHER

CPAP

Control GroupEXPERIMENTAL GROUP
Upper Airway Toning for Improve the Compliance of CPAPPROCEDURE

Upper Airway Toning for Improve the Compliance of CPAP

EXPERIMENTAL GROUP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with OSA using CPAP

You may not qualify if:

  • Neurological Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisiolistic

L'Hospitalet de Llobregat, Barcelona, 08901, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eduard Estelle

    Hospital Universitari General de Catalunya

    PRINCIPAL INVESTIGATOR

  • Anna Bagué

    Fisiolístic

    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 CHAIR

Central Study Contacts

Eduard Estelle, Doctor

CONTACT

647676131annabague@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2013

First Posted

September 5, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

ES(1)