OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Instituto de Investigación Marqués de Valdecilla

Status and phase: Enrolling; Phase 3

Conditions: Obstructive Sleep Apnea

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06681974

OMTOSA

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

control group

Active Comparator group

Description:

indications on the hygienic-dietary measures

Treatment:

Behavioral: CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.

experimental

Experimental group

Description:

indications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks

Treatment:

Biological: EXPERIMENTAL: program of exercises that will be composed of 4 blocks