Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06681974

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Led by Instituto de Investigación Marqués de Valdecilla · Updated on 2024-11-14

30

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Diagnosis of mild to moderate Obstructive Sleep Apnea without need for CPAP or other advanced treatments
  • Patients who refused or are not candidates for CPAP or other treatments
  • Age greater than 18 years and less than 70 years
Not Eligible

You will not qualify if you...

  • Craniofacial malformations, severe developmental delay, or intellectual disability
  • Diagnosis of neurodegenerative disease
  • Limited tongue mobility, ankyloglossia, or Temporo-Mandibular Joint pathology
  • Regular use of hypnotic medications
  • Bulbar pathologies
  • Central sleep apnea with more than 50% of total sleep time
  • Obesity grade II or higher
  • Severe cardiovascular, neuromuscular, or pulmonary disease or chronic oxygen use
  • Hypoventilation-obesity syndrome
  • Refusal to participate despite meeting inclusion criteria and no exclusions

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital universitario Marques de Valdecilla

Santander, Spain

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA | DecenTrialz