Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2014-07-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Obstructive Sleep Apnea on Central Blood Pressure and Kidney and Endothelial Function
NCT00947479
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
NCT01336556
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
NCT01461486
The Effect of Remote Diagnosis and Treatment on 24 Hour Ambulatory Blood Pressure Rhythm of OSA Patients
NCT06064630
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
NCT04262960
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mandibular advancement device
Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea
Mandibular advancement device
Use of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea.
Placebo
Oral appliance identical to the mandibular advancement device without mandibular advancement
Placebo
Placebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mandibular advancement device
Use of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea.
Placebo
Placebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mouth opening of at least 30 mm
* Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour
* Agree to participate in the study by signing the informed consent
Exclusion Criteria
* Self-reported severe or terminal Illness
* Physical disability
* Inability to communicate verbally
* Dementia in the Mini-Mental State Examination
* Plan to move to a different a city or to be institutionalized in the next year
* Participation in another clinical trial
* Less than eight teeth, periodontal disease, or TMJ problems
65 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Denis Martinez
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Denis Martinez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Rio Grande do Sul
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cintia Z Fiori
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
140069
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.