CompletedNot Applicable

Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices

Sweden313 participantsStarted 2014-05

Plain-language summary

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year. This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

Who can participate

Age range

18 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: * The diagnosis of obstructive sleep apnea with AHI \> 15 * Odontological status that allows retention of oral devices and with at least one molar in each quadrant * Maximal protrusion \>6 mm * Subject giving his/her informed concent * Understands and can communicate in Swedish * Subject understands the instruction on how to put on the polygraphy equipment at home * Valid AHI data at baseline respiratory analysis Exclusion Criteria: * age\< 18 år * BMI \>35 * Jaw complaints requiring treatment the past year * Pain or locking of the jaw at the enrollment visit * At the discretion of the investigator judged not being able to attach to the study directives * Hypersensitive to the material of the devices * Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment

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

Apnoea-Hypopnea-Index (AHI)

Timeframe: 9 weeks after start of study

Trial details

NCT IDNCT02148510

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials