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OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

RecruitingPhase 3Ages 18 Years - 70 YearsAllInstituto de Investigación Marqués de Valdecilla
NCT06681974 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP. The objective is to determine the effect of OMT in the general population with mild-moderate OSA. The overall study design will be a randomized controlled clinical trial with parallel groups. Both the control group and the intervention group will receive the same indications on the hygienic-dietary measures to be followed. The intervention group will also follow an exercise program based on OMT for 20 weeks. The effect on the apnea-hypopnea index and other variables will be determined by means of respiratory polygraphy before and after the intervention.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Acceptance and signature of the informed consent * Diagnosis of OSA with mild-moderate AHI without criteria for treatment with CPAP and/or other treatments (DAM). * Patients who refused CPAP, were not candidates and/or refused DAM. * Age \> 18 years and \< 70 years Exclusion Criteria: * Craniofacial malformations. Severe developmental delay. Intellectual disability. * Diagnosis of neurodegenerative disease. * Limited tongue mobility/presence of ankyloglossia as well as Temporo-Mandibular Joint pathology. * Regular use of hypnotic medications * Bulbar pathologies * AHI of central origin above 50% of the total sleep time. * Obesity grade II or more. * Severe cardiovascular, neuromuscular or pulmonary pathology or chronic domiciliary oxygen use. Hypoventilation-obesity syndrome. * Refuse to participate in the clinical trial despite fulfilling the inclusion criteria and not presenting any exclusion criteria.
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What it tests

  • CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.
  • EXPERIMENTAL: program of exercises that will be composed of 4 blocks
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Where

1 site
Hospital universitario Marques de Valdecilla
Santander, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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