OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Phase 3

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06681974
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Study First Submitted: 2024-07-17
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy	12 months

Secondary Outcome Measures

Name	Time	Method
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	12 months
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.	12 months
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).	12 months

Trial Locations

Locations (1)

Hospital universitario Marques de Valdecilla; 🇪🇸 Santander, Spain