Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive sleep apnea, OSA, MAD, CPAP, Orthodontics
Brief summary
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.
Interventions
18 months of treatment with MAD in total.
DEVICEContinuous positive airway pressure (CPAP)
6 months of treatment with CPAP in total.
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Investigator blinded to the DISE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Objectively diagnosed with moderate OSA (AHI 15-29) * \>/= 18 years * BMI \</= 35 and neck circumference \<44cm * Fully sanitised at their own dentist (no periodontitis or caries requiring treatment. Periodontal bone loss \<50%) * \>/= 20 teeth. * Evenly distributed occlusal contacts
Exclusion criteria
* Known craniofacial anomalies * General inflammatory joint diseases * Maximal protrusion of the mandible \< 6 mm * Severe deep bite * Anterior open bite * Severe attrition * Severe bruxism and involuntary mandibular movements * Conditions demanding treatment such as temporomandibular disorders (TMD) * Chronically pronounced nasal stenosis * Hypertrophic tonsils (tonsil size 3-4) * Prior blood clot in the brain or in the heart * Heart arrythmias * Other severe systemic diseases * Epilepsia * Allergies towards peanuts, soy or egg * Consumption of morphine or other sedatives which cannot be paused * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI) | From enrollment to the end of treatment at 24 months | Defined as the number of apneas and hypopneas per hour of sleep, with higher values indicating greater severity |
| Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Oxygen Desaturation Index (ODI) | From enrollment to the end of treatment at 24 months | Defined as the number of oxygen desaturation events per hour of sleep, with higher values indicating more severe nocturnal hypoxemia |
| Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by acoustic pharyngo- and rhinometry | From enrollment to the end of treatment at 24 months | Measured as volume, mean area, minimum cross-sectional area (MCA), distance to MCA and calculated resistance |
| Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Epworth Sleepiness Scale (ESS) | From enrollment to the end of treatment at 24 months | Scale 0-24, higher scores indicate greater daytime sleepiness |
| Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Pittsburgh Sleep Quality Index (PSQI) | From enrollment to the end of treatment at 24 months | Scale 0-21, higher scores indicate worse sleep quality |
| Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Berlin Questionnaire (BQ) | From enrollment to the end of treatment at 24 months | 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 |
| Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Short Form 36 (SF-36) | From enrollment to the end of treatment at 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by lateral cephalogram | At baseline and at the end of treatment at 24 months | Measured with standardized cephalometric angular measurements |
| The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by cone-beam CT (CBCT) | At baseline and at the end of treatment at 24 months | Assessment of upper airway dimensions |
| The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by VOTE-classification | DISE is performed before treatment | 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 |
| 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 | DISE is performed before treatment. | 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 |
| 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 | At baseline and at the end of treatment at 24 months | Measured with standardized cephalometric angular measurements |
| 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) | At baseline and at the end of treatment at 24 months | Assessment of upper airway dimensions |
| 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) | From enrollment to the end of treatment at 24 months | The DC/TMD is applied using both patient-reported symptom questionnaires and a structured clinical examination |
| 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 | From enrollment to the end of treatment at 24 months | Dental occlusion assessed by intraoral scans and number of dental contacts in intercuspidal position (ICP) |
| 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 | From enrollment to the end of treatment at 24 months | Measured in newtons (N) |
| 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) | From enrollment to the end of treatment at 24 months | 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 |
| 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) | From enrollment to the end of treatment at 24 months | 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 |
Countries
Denmark
Contacts
CONTACTClara Hartogsohn, PhD Student
CONTACTLiselotte Sonnesen, Professor
PRINCIPAL_INVESTIGATORLiselotte Sonnesen, Professor
University of Copenhagen
Outcome results
None listed