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 range18 Years

SexALL

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

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