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

University of Copenhagen

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Device: Continuous positive airway pressure (CPAP); Device: Mandibular advancement device (MAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT07677332

102-11297/25-3000

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

MAD-group

Experimental group

Description:

Group starting with the MAD treatment

Treatment:

Device: Mandibular advancement device (MAD)

Device: Continuous positive airway pressure (CPAP)

CPAP-group

Experimental group

Description:

Group starting with the CPAP treatment

Treatment:

Device: Mandibular advancement device (MAD)

Device: Continuous positive airway pressure (CPAP)