Obstructive Sleep Apnea
Conditions
Keywords
human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism, cost
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
Interventions
DEVICEMonobloc
Construction fitted to upper and lower jaw
DEVICEBibloc
Biblock construction
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnoea-Hypopnea-Index (AHI) | 9 weeks after start of study | AHI defined by American Academy of Sleep Medicine (AASM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index (ODI) | 9 weeks | Number of episodes per hour with arterial oxygen saturation decline of 3% or more |
| Sleepiness | 9 weeks and 1 year | Epworth Sleepiness Scale (ESS) |
| Sleep bruxism | 9 weeks | Bruxism episodes during sleep |
| Adverse events | 1 year | Subject reported and objective investigator observed events |
| Quality of life | 9 weeks and 1 year | Functional Outcomes of Sleep Questionnaire (FOSQ ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost of care | 1 year | Total cost calculation including the device, repairs and adjustments and consumption of dentist time |
Countries
Sweden
Outcome results
None listed