OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Last updated: November 12, 2024
Sponsor: Instituto de Investigación Marqués de Valdecilla
Overall Status: Active - Recruiting

Phase

3

Condition

Sleep Apnea Syndromes

Treatment

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

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

Clinical Study ID

NCT06681974
OMTOSA
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  • Acceptance and signature of the informed consent

  • Diagnosis of OSA with mild-moderate AHI without criteria for treatment with CPAPand/or other treatments (DAM).

  • Patients who refused CPAP, were not candidates and/or refused DAM.

  • Age > 18 years and < 70 years

Exclusion

Exclusion Criteria:

  • Craniofacial malformations. Severe developmental delay. Intellectual disability.

  • Diagnosis of neurodegenerative disease.

  • Limited tongue mobility/presence of ankyloglossia as well as Temporo-MandibularJoint 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 domiciliaryoxygen use. Hypoventilation-obesity syndrome.

  • Refuse to participate in the clinical trial despite fulfilling the inclusioncriteria and not presenting any exclusion criteria.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: EXPERIMENTAL: program of exercises that will be composed of 4 blocks
Phase: 3
Study Start date:
May 01, 2023
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • Hospital universitario Marques de Valdecilla

    Santander,
    Spain

    Active - Recruiting

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