Obstructive Sleep Apnea (OSA)NCT07677332
Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea
A study testing Mandibular advancement device (MAD) and Continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea (OSA), run by University of Copenhagen at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Mandibular advancement device (MAD) and Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Known craniofacial anomalies
- General inflammatory joint diseases
- Maximal protrusion of the mandible < 6 mm
- Severe deep bite
- Anterior open bite
- Severe attrition
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
University of Copenhagen
Copenhagen, 2200
Clara Hartogsohn, PhD Student, +4528909559, clara.hartogsohn@sund.ku.dk
Liselotte Sonnesen, Professor, alson@sund.ku.dk
About this study
Official title: Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Mandibular advancement device (MAD), Continuous positive airway pressure (CPAP)
- Keywords
- Obstructive sleep apnea, OSA, MAD, CPAP, Orthodontics
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MAD-group | Experimental | Group starting with the MAD treatment Receives: Device: Mandibular advancement device (MAD); Device: Continuous positive airway pressure (CPAP) |
| CPAP-group | Experimental | Group starting with the CPAP treatment Receives: Device: Mandibular advancement device (MAD); Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Defined as the number of oxygen desaturation events per hour of sleep, with higher values indicating more severe nocturnal hypoxemia
Measured: 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
Measured as volume, mean area, minimum cross-sectional area (MCA), distance to MCA and calculated resistance
Measured: 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)
Scale 0-24, higher scores indicate greater daytime sleepiness
Measured: 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)
Scale 0-21, higher scores indicate worse sleep quality
Measured: 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)
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
Measured: 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)
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
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (11)
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
Measured: 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)
Assessment of upper airway dimensions
Measured: 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
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
Measured: 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
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
Measured: 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
Measured with standardized cephalometric angular measurements
Measured: 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)
Assessment of upper airway dimensions
Measured: 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)
The DC/TMD is applied using both patient-reported symptom questionnaires and a structured clinical examination
Measured: 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
Dental occlusion assessed by intraoral scans and number of dental contacts in intercuspidal position (ICP)
Measured: 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
Measured in newtons (N)
Measured: 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)
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
Measured: 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)
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
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liselotte Sonnesen, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677332
- Sponsor's protocol ID
- 102-11297/25-3000
- Status last verified
- Jan 2026
- First submitted
- 20 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07677332
- Acronym / sponsor ID
- 102-11297/25-3000
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive sleep apnea, OSA, MAD, CPAP, Orthodontics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD-group | Experimental | Device: Mandibular advancement device (MAD), Device: Continuous positive airway pressure (CPAP)Group starting with the MAD treatment |
| CPAP-group | Experimental | Device: Mandibular advancement device (MAD), Device: Continuous positive airway pressure (CPAP)Group starting with the CPAP treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- Known craniofacial anomalies
- General inflammatory joint diseases
- Maximal protrusion of the mandible < 6 mm
- Severe deep bite
- Anterior open bite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular advancement device (MAD)18 months of treatment with MAD in total. | Device | CPAP-group, MAD-group |
| Continuous positive airway pressure (CPAP)6 months of treatment with CPAP in total. | Device | CPAP-group, MAD-group |
Primary outcome
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
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liselotte Sonnesen, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device (MAD) and Continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea (OSA), run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Hartogsohn, PhD Student (+4535321136, clara.hartogsohn@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.