UnknownNot Applicable

Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese

60 participantsStarted 2016-05-12

Plain-language summary

This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes.

Who can participate

Age range

20 Years – 65 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: * BMI ≥40 kg/m² and ≤ 49,9 kg/m² * Female and male patients (Both of gender patients) with ages between 20 to 65 years old * Obstructive Sleep Apnea (OSA) diagnosis by polysomnography Exclusion Criteria: * sedative drugs users * Oxygen-dependent or decompensated lung disease * Decompensated congestive heart failure * Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia) * craniofacial deformities carriers * previous OSAS Diagnosis and treatment * Active Oncological diseases in the last ten years * Patients with less than 8 teeth per arcade; * Patients with advanced periodontitis;

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

Quality of life

Timeframe: 10 minutes

Daytime sleepiness

Timeframe: 5 minutes

Quality of sleep

Timeframe: 5 minutes

Trial details

NCT IDNCT03517150

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-19

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials