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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
313
Västmanland County Hospitals
Västerås, Västmanland County, Sweden
Postgraduate Dental Education Center
Örebro, Sweden
Apnoea-Hypopnea-Index (AHI)
AHI defined by American Academy of Sleep Medicine (AASM)
Time frame: 9 weeks after start of study
Oxygen Desaturation Index (ODI)
Number of episodes per hour with arterial oxygen saturation decline of 3% or more
Time frame: 9 weeks
Sleepiness
Epworth Sleepiness Scale (ESS)
Time frame: 9 weeks and 1 year
Quality of life
Functional Outcomes of Sleep Questionnaire (FOSQ )
Time frame: 9 weeks and 1 year
Sleep bruxism
Bruxism episodes during sleep
Time frame: 9 weeks
Adverse events
Subject reported and objective investigator observed events
Time frame: 1 year
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