Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea
Key facts
- Who runs it
- University of Copenhagen
- Where
- Copenhagen, DenmarkSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 70 people, planned
- Started
- Aug 2026
- Expected to end
- Aug 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Mandibular advancement device (MAD)
- Continuous positive airway pressure (CPAP)
- Record updated
- 30 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior blood clot in the brain or in the heart
- General inflammatory joint diseases
- Conditions demanding treatment such as temporomandibular disorders (TMD)
- Heart arrythmias
- Other severe systemic diseases
- Allergies towards peanuts, soy or egg
- Known craniofacial anomalies
- Maximal protrusion of the mandible < 6 mm
- Severe deep bite
- Anterior open bite
- Severe attrition
- Severe bruxism and involuntary mandibular movements
- Chronically pronounced nasal stenosis
- Hypertrophic tonsils (tonsil size 3-4)
- Epilepsia
- Consumption of morphine or other sedatives which cannot be paused
- Pregnant or breast-feeding women
Where in Denmark
- University of CopenhagenCopenhagen, DenmarkContact: Clara Hartogsohn, PhD StudentNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- MAD-groupTreatment being tested
Group starting with the MAD treatment
Treatment: Mandibular advancement device (MAD) and Continuous positive airway pressure (CPAP)
- CPAP-groupTreatment being tested
Group starting with the CPAP treatment
Treatment: Mandibular advancement device (MAD) and Continuous positive airway pressure (CPAP)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea
- Record updated
- 30 June 2026