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New treatment option for Obstructive Sleep Apnea
Official title OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
ClinicalTrials.gov ID: NCT06681974
What this study is testing
What is EXPERIMENTAL: program of exercises that will be composed of 4 blocks?
EXPERIMENTAL: program of exercises that will be composed of 4 blocks is an investigational medicine, being studied as a potential treatment for obstructive sleep apnea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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 likely can't join 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santander, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santander, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.