OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
Recruiting
Phase 3
Interventional Study
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 30 (estimated)
- Sponsor
- Instituto de Investigación Marqués de Valdecilla · Other
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About This Trial
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 overal…
Trial Locations
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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 …
Contacts
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