Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea

Official title

Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea

Overview

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

• Device Mandibular advancement device (MAD)
  18 months of treatment with MAD in total.
• Device Continuous positive airway pressure (CPAP)
  6 months of treatment with CPAP in total.

Primary outcome measures

• Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI) [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) [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 [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) [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) [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) [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) [Time frame: From enrollment to the end of treatment at 24 months]

Secondary outcome measures (11)

• The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by lateral cephalogram [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) [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 [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 [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 [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) [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) [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 [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 [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) [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) [Time frame: From enrollment to the end of treatment at 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• University of Copenhagen — Copenhagen

Identifiers

NCT: NCT07677332 · 102-11297/25-3000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗