Obstructive sleep apnea (OSA) is a frequent illness related to sleep and breathing with many symptoms and complications. The primary choices of treatment are continuous positive airway pressure (CPAP) and removable appliance for protruding the mandible when sleeping (MAD). Treatment with CPAP is superior to treatment with MAD but many patients don't tolerate CPAP why they seek treatment with MAD. In Denmark, treatment with MAD is not free of charge unlike treatment with CPAP and MAD is therefore not offered systematically to the patients. The same applies to adjustment, control and effect of the MAD treatment. MAD treatment has a positive effect on OSA in general but the effect varies due to differences in selection of patients and lack of specifying who performs and evaluates MAD treatment, the effect on sleep and possible side effects in muscles and the temporomandibular joint as well as the occlusion during treatment. It is therefore of great importance to investigate the effect of MAD treatment as well as short- and long-term side effects. The aim is therefore to compare the treatment effect of MAD and CPAP and how significant the investigation of the airways and the face is for the treatment effect and possible side effects. The project is a 4-year investigation and 70 adult patients diagnosed with moderate OSA are included. The results from the investigation will be of great importance for the choice of treatment and prognosis for the individual patient and socio-economic since the treatment of OSA could be tailored the individual patient and the treatment effect optimised.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
18 months of treatment with MAD in total.
6 months of treatment with CPAP in total.
University of Copenhagen
Copenhagen, Denmark
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI)
Defined as the number of apneas and hypopneas per hour of sleep, with higher values indicating greater severity
Time frame: From enrollment to the end of treatment at 24 months
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Oxygen Desaturation Index (ODI)
Defined as the number of oxygen desaturation events per hour of sleep, with higher values indicating more severe nocturnal hypoxemia
Time frame: From enrollment to the end of treatment at 24 months
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by acoustic pharyngo- and rhinometry
Measured as volume, mean area, minimum cross-sectional area (MCA), distance to MCA and calculated resistance
Time frame: From enrollment to the end of treatment at 24 months
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Epworth Sleepiness Scale (ESS)
Scale 0-24, higher scores indicate greater daytime sleepiness
Time frame: From enrollment to the end of treatment at 24 months
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Pittsburgh Sleep Quality Index (PSQI)
Scale 0-21, higher scores indicate worse sleep quality
Time frame: From enrollment to the end of treatment at 24 months
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Berlin Questionnaire (BQ)
The Berlin Questionnaire classifies individuals as high or low risk for obstructive sleep apnea based on three symptom categories; high risk is defined as having two or more positive categories
Time frame: From enrollment to the end of treatment at 24 months
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Short Form 36 (SF-36)
The SF-36 assesses health-related quality of life across eight domains, each scored from 0 to 100, with higher scores indicating better health status
Time frame: From enrollment to the end of treatment at 24 months
The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by lateral cephalogram
Measured with standardized cephalometric angular measurements
Time frame: At baseline and at the end of treatment at 24 months
The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by cone-beam CT (CBCT)
Assessment of upper airway dimensions
Time frame: At baseline and at the end of treatment at 24 months
The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by VOTE-classification
The VOTE classification evaluates obstruction at four anatomical levels (velum, oropharynx, tongue base, epiglottis), with each site scored according to the degree of collapse (0-2), where higher scores indicate greater obstruction
Time frame: DISE is performed before treatment
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by VOTE-classification
The VOTE classification evaluates obstruction at four anatomical levels (velum, oropharynx, tongue base, epiglottis), with each site scored according to the degree of collapse (0-2), where higher scores indicate greater obstruction
Time frame: DISE is performed before treatment.
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by lateral cephalogram
Measured with standardized cephalometric angular measurements
Time frame: At baseline and at the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by cone-beam CT (CBCT)
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Assessment of upper airway dimensions
Time frame: At baseline and at the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
The DC/TMD is applied using both patient-reported symptom questionnaires and a structured clinical examination
Time frame: From enrollment to the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by dental occlusion
Dental occlusion assessed by intraoral scans and number of dental contacts in intercuspidal position (ICP)
Time frame: From enrollment to the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by bite-force
Measured in newtons (N)
Time frame: From enrollment to the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by short-form Oral Health Impact Profile (OHIP-14)
The OHIP-14 assesses oral health-related quality of life across seven domains, with each item scored from 0 (never) to 4 (very often), yielding a total score ranging from 0 to 56, where higher scores reflect greater impairment
Time frame: From enrollment to the end of treatment at 24 months
The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by Nordic Oro-facial Test-Screening (NOT-S)
The NOT-S consists of 12 domains (6 interview-based and 6 examination-based), each scored as 0 or 1, yielding a total score from 0 to 12, with higher scores indicating more severe orofacial dysfunction
Time frame: From enrollment to the end of treatment at 24 months