OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstituto de Investigación Marqués de Valdecilla
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 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
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov