OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

NCT ID: NCT06681974

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control group

indications on the hygienic-dietary measures

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital universitario Marques de Valdecilla

Santander, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

javier Uribarri

Role: primary

javier.bolado@scsalud.es

942203389

Other Identifiers

OMTOSA

Identifier Type: -

Identifier Source: org_study_id