Oropharyngeal myofunctional therapy for obstructive sleep apnea
RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION
PHASE3 · Instituto de Investigación Marqués de Valdecilla · NCT06681974
This study tests if a 20-week exercise program using oropharyngeal myofunctional therapy can help people with mild to moderate obstructive sleep apnea breathe better while they sleep.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto de Investigación Marqués de Valdecilla (other) |
| Locations | 1 site (Santander) |
| Trial ID | NCT06681974 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of oropharyngeal myofunctional therapy (OMT) as a conservative treatment for patients with mild to moderate obstructive sleep apnea (OSA). Participants will be randomly assigned to either an intervention group, which will engage in a 20-week exercise program based on OMT, or a control group that will receive standard hygienic-dietary measures. The study aims to assess changes in the apnea-hypopnea index and other relevant variables through respiratory polygraphy before and after the intervention. The trial seeks to provide insights into the efficacy of OMT in improving OSA symptoms and overall patient health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of mild to moderate obstructive sleep apnea who are not suitable for CPAP or other treatments.
Not a fit: Patients with severe obstructive sleep apnea, craniofacial malformations, or significant comorbidities may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could offer a non-invasive treatment option for patients with mild to moderate obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promising results for similar conservative treatments in managing obstructive sleep apnea, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Santander
- Hospital universitario Marques de Valdecilla — Santander, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Oropharyngeal myofunctional therapy