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ID
Source
Brief title
Health condition
Obstructive sleep apnea
Obstructiefslaapapneu
Mandibular advancement device (MAD)
Mandibulair repositie apparaat (MRA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
• decrease in AHI of at least 50% and AHI< 10/hour, OR
• decrease in AHI below 5/hour if baseline AHI was < 10/hour
Secondary outcome
Decrease in ESS questionnaire, adverse effects, therapy score (1-9), any change in AHI, FOSQ questionnaire, SF-36 questionnaire, compliance.
Background summary
Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. It is characterized by partial or complete collapse of the upper airway. This collapse can be caused by multiple factors, including craniofacial anatomy, soft tissue characteristics, age, obesity and gender. There are multiple treatment options, including surgical procedures, oral appliances and continuous positive airway pressure (CPAP). Treatment with a mandibular advancement device (MAD, also known as mandibular repositioning appliance (MRA), has been extensively described. The choice for using an MAD for treating symptomatic OSA is usually based on the severity of the disease (expressed in the apnea-hypopnea index (AHI) and on the state of dentition. Whether the MAD is effective in treating OSA in an individual patient can only be assessed after multiple months of using the MAD. Until now we do not know which patient characteristics at baseline can predict when treatment with an MAD is effective. As such, improving phenotyping of patients before starting therapy with MAD can be a major improvement in the treatment of symptomatic OSA.
The primary objective of our study is to define a set of patient characteristics that can predict the effectiveness of an MAD in treating symptomatic OSA. The aim of our study is to develop a prediction model to calculate the success rate in an individual patient, that can be applied in daily practice.
We will perform a multi-centre, prospective observational study, including at least 380 patients during a time period of 6 to 12 months. Using multiple and logistic regression analysis we will identify predictors of effective treatment of symptomatic OSA using MAD.
Study objective
The primary objective of our study is to define a set of patient characteristics that can predict the effectiveness of an MAD in treating symptomatic OSA. The aim of our study is to develop a prediction model to calculate the success rate in an individual patient, that can be applied in daily practice.
Study design
Baseline, visit 3 months after baseline, possible visit 6 months after baseline (if MAD therapy is unsuccessful after 3 months)
Intervention
Multiple questionnaires
Control polygraphy
Lateral cephalogram
Inclusion criteria
• 18 years or older at time of inclusion
• Established OSA (AHI of 5/hour or more on poly(somno)graphy)
• Symptomatic OSA (ESS-score > 10)
Exclusion criteria
• patients with dental status hindering the use of MAD such as periodontal and dental problems, severe temporomandibular disorders. Patients with dental implants are allowed to participate.
• patients who cannot be properly instructed on the use of MAD, including patients with mental illness
• presence of complete nasal obstruction
• presence of a tumour in the upper airways
• adenotonsillar hypertrophy grades 3 and 4
• body mass index > 40kg/m2
• presence of obesity hypoventilation syndrome
• presence of any neuromuscular disorder
• chronic obstructive lung disease (COPD) with documented hypercapnia
• central sleep apnea component of > 50% of total AHI
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7458 |
| NTR-old | NTR7700 |
| CCMO | NL65332.100.18 |
| OMON | NL-OMON48663 |