OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
Key facts
- Who runs it
- Instituto de Investigación Marqués de Valdecilla
- Where
- Santander, SpainSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 30 people, planned
- Started
- 1 May 2023
- Planned end
- 1 Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.
- EXPERIMENTAL: program of exercises that will be composed of 4 blocks
- Record updated
- 14 November 2024
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Regular use of hypnotic medications
- Diagnosis of neurodegenerative disease
- Severe cardiovascular, neuromuscular or pulmonary pathology or chronic domiciliary oxygen use. Hypoventilation-obesity syndrome
- Craniofacial malformations. Severe developmental delay. Intellectual disability
- Limited tongue mobility/presence of ankyloglossia as well as Temporo-Mandibular Joint pathology
- Bulbar pathologies
- AHI of central origin above 50% of the total sleep time
- Obesity grade II or more
- Refuse to participate in the clinical trial despite fulfilling the inclusion criteria and not presenting any exclusion criteria
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Spain
- Hospital Universitario Marqués de ValdecillaSantander, SpainContact: javier UribarriTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- control groupExisting treatment, for comparison
indications on the hygienic-dietary measures
Treatment: CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.
- experimentalTreatment being tested
indications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks
Treatment: EXPERIMENTAL: program of exercises that will be composed of 4 blocks
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION
- Fit questions
- Built from NCT06681974, who can take part
- Record updated
- 14 November 2024