the primary objective of our study is to define a set of patient characteristics that can predict the effectiveness of an MRA in treating symptomatic OSA. The aim of our study is to develop a prediction model to calculate the success rate in an…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
effective treatment with MRA is described as a reduction in AHI of at least 50%
combined with an AHI< 10. If AHI at baseline was < 10, the index must decrease
to at least < 5.
Secondary outcome
not applicable
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
repositioning appliance (MRA) has been extensively described. The choice for
using an MRA 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 MRA is effective in treating OSA in an individual
patient can only be assessed after multiple months of using the MRA. Until now
we do not know which patient characteristics at baseline can predict when
treatment with an MRA is effective. As such, improving phenotyping of patients
before starting therapy with MRA can be a major improvement in the treatment of
symptomatic OSA.
Study objective
the primary objective of our study is to define a set of patient
characteristics that can predict the effectiveness of an MRA 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
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 MRA.
Study burden and risks
since MRA is already a standard treatment option for OSA patients, it poses no
significant risks for participants in this study besides known side effects of
MRA therapy. While especially in patients with severe OSA, CPAP is often the
preferred first therapeutic option, it has not been established that MRA cannot
provide an effective treatment in this group. Treatment with MRA may however
lead to more frequent visits, since the device needs to be titrated to achieve
maximal effectiveness. All study participants will need to undergo a lateral
cephalogram for measuring of craniofacial features and a second and possibly a
third poly(somno)graphy (PG) to measure the AHI while sleeping with an MRA.
Molengracht 21
Breda 4818CK
NL
Molengracht 21
Breda 4818CK
NL
Listed location countries
Age
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 MRA such as less than 10 teeth per dental arch, 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 MRA, 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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65332.100.18 |
| OMON | NL-OMON22428 |