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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital universitario Marques de Valdecilla
RECRUITING
Santander
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 30
Treatments
Active_comparator: control group
indications on the hygienic-dietary measures
Experimental: experimental
indications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Marqués de Valdecilla

This content was sourced from clinicaltrials.gov