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NCT Number: NCT06681974

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital universitario Marques de Valdecilla

Santander, Spain

Location status: Recruiting

Location contact

javier Uribarri

CONTACT

[email protected]

942203389

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral
  • 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.

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

Biological

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).

Primary outcomes

  1. the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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).

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Marqués de Valdecilla

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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