Status:
COMPLETED
Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)
Lead Sponsor:
Quironsalud
Conditions:
Obstructive Sleep Apnea-hypopnea Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
• Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to stop and start repeatedly during sleep. There are several types of sleep apnea, the...
Detailed Description
INTRODUCTION Obstructive sleep apnea/hypopnea syndrome (OSAHS) has become one of the more serious health problems worldwide (Mendes et al., 2014). Because of its relationship with obesity, its prevale...
Eligibility Criteria
Inclusion
- Age between 18-75 years
- Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology
- Consent signed
Exclusion
- BMI \> 40 kg/m²
- Inability to fill up questionnaires
- Severe drug or alcohol abuse
- Hypnotic medication
- Not controlled coronary disease
- Decompensated Heart failure
- Stroke
- Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…)
- Neuromuscular disease (like Duchenne)
- Craniofacial deformities.
- Active oncologic process.
- Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, Mandibular Advancement Device (MAD) or CPAP).
- Once the patient accepted and signed consent and met inclusion criteria, they will be attended by Ent specialist to rule out:
- Severe upper airway obstruction (Complete nose obstruction, Tonsils grade IV/IV )
- Presence of tongue tie (Marchesani protocol) with limitation of tongue movements
- Antecedents or presence of temporomandibular joint disorders
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04438785
Start Date
March 1 2019
End Date
September 30 2020
Last Update
February 11 2021
Active Locations (2)
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1
Hospital Quironsalud Campo de Gibraltar
Los Barrios, Cadiz, Spain, 11379
2
Hospital Quironsalud Marbella
Marbella, Malaga, Spain, 29603