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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Copenhagen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

Known craniofacial anomalies

General inflammatory joint diseases

Maximal protrusion of the mandible < 6 mm

Severe deep bite

Trial design

Design model

Crossover

Treatments tested in this trial

  • Mandibular advancement device (MAD)

    Device

    18 months of treatment with MAD in total.

  • Continuous positive airway pressure (CPAP)

    Device

    6 months of treatment with CPAP in total.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: MAD-groupExperimental treatment 2 interventions
Group B: CPAP-groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: