Clinical trial NCT06681974: OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
Official title: RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Keywords: Oropharyngeal myofunctional therapy
Obstructive Sleep Apnea
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Primary outcomes:
measure: the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy
timeFrame: 12 months
Secondary outcomes:
measure: the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea on nocturnal and diurnal clinical variable measured by means of the Epworth Test
timeFrame: 12 months
measure: the impact of Oropharyngeal myofunctional therapy in Obstructive Sleep Apnea treatment on quality of life in the general population diagnosed with mild-moderate OSA using the EuroQol-5D questionnaire.
timeFrame: 12 months
measure: the degree of tolerance of Oropharyngeal myofunctional therapy in patients diagnosed with mild-moderate Obstructive Sleep Apnea using a Likert-type design Visual Analog Scale Rating and Pairwise Comparison Rating Scale (VAS-RRP).
timeFrame: 12 months
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital universitario Marques de Valdecilla
Study officials:
References: