OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Официальное название

RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION

Обзор

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.

Вмешательства

• Поведенческое CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.
  * Establish a regular sleep schedule * Do not stay in bed longer than our regular sleep schedule. * Avoid naps during the day * Do not perform exciting activities and/or activities that demand physical or mental energy in the 3 hours prior to going to bed. * Avoid the use of mobile screens, as well as exposure to intense light in the 3 hours prior to going to bed. * Follow a healthy bedtime routine * Healthy lifestyle habits: avoid tobacco, alcohol and other toxic substances.
• Биопрепарат EXPERIMENTAL: program of exercises that will be composed of 4 blocks
  the first is the work of the soft palate (retropalatine level), the second is the work of the functionality of the tongue (retroglossus level), the third is the work of the position of the hyoid bone (hypopharyngeal level), and the fourth is work on anterior head tilt and craniocervical extension (anterior head posture).

Первичные конечные точки

• the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy [Срок оценки: 12 months]

Вторичные конечные точки (3)

• 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 [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital universitario Marques de Valdecilla — Santander

Идентификаторы

NCT: NCT06681974 · OMTOSA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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