OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

NCT06681974 | Recruiting Phase 3

• 1 other identifier: OMTOSA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Oropharyngeal myofunctional therapy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (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

  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

Study Arms (2)

control group

ACTIVE COMPARATOR

indications on the hygienic-dietary measures

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

experimental

EXPERIMENTAL

indications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks

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

Interventions

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.

control group

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).

experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Hospital universitario Marques de Valdecilla

Santander, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: November 12, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)