RecruitingPhase 3

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Spain30 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT06681974

SponsorInstituto de Investigación Marqués de Valdecilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials