Clinical trial NCT02148510: Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices
Official title: Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: human
sleep apnea
adults
oral appliance
efficacy
safety
polygraphy
bruxism
cost
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Eligibility criteria: 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

Primary outcomes:
measure: Apnoea-Hypopnea-Index (AHI)
timeFrame: 9 weeks after start of study
Secondary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: 9 weeks
measure: Sleepiness
timeFrame: 9 weeks and 1 year
measure: Quality of life
timeFrame: 9 weeks and 1 year
measure: Sleep bruxism
timeFrame: 9 weeks
measure: Adverse events
timeFrame: 1 year
Other outcomes:
measure: Cost of care
timeFrame: 1 year
Locations:
city: Västerås
country: Sweden
facility: Västmanland County Hospitals
state: Västmanland
city: Örebro
country: Sweden
facility: Postgraduate Dental Education Center
Study officials:
affiliation: Västmanlands County hospital Västerås, Sweden
name: Goran Isacsson, assoc prof
role: STUDY_CHAIR
References:
citation: Isacsson G, Nohlert E, Fransson AMC, Bornefalk-Hermansson A, Wiman Eriksson E, Ortlieb E, Trepp L, Avdelius A, Sturebrand M, Fodor C, List T, Schumann M, Tegelberg A. Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial. Eur J Orthod. 2019 Jan 23;41(1):80-88. doi: 10.1093/ejo/cjy030.