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Upper Airway Toning for Improve the Compliance of CPAP

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936038
Enrollment
110
Registered
2013-09-05
Start date
2013-06-30
Completion date
2014-02-28
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

CPAP, Upper Airway Toning, Obstructive Sleep Apnoea

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

Interventions

OTHERCPAP

CPAP

PROCEDUREUpper Airway Toning for Improve the Compliance of CPAP

Upper Airway Toning for Improve the Compliance of CPAP

Sponsors

Fisiolistic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with OSA using CPAP

Exclusion criteria

* Neurological Patients

Design outcomes

Primary

MeasureTime frameDescription
CPAP compliance3 monthsnominal variable

Secondary

MeasureTime frameDescription
Sleep Apnea Quality of Life Index (SAQLI) Test3 monthsTest of quality of life

Countries

Spain

Contacts

Primary ContactEduard Estelle, Doctor
annabague@hotmail.com647676131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026