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NCT Number: NCT07677332

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

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, 2200, Denmark

Location contact

Clara Hartogsohn, PhD Student

CONTACT

[email protected]

+4528909559

Clara Hartogsohn, PhD Student

SUB_INVESTIGATOR

Liselotte Sonnesen, Professor

CONTACT

[email protected]

Liselotte Sonnesen, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

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

    Time frame: At baseline and at the end of treatment at 24 months

    Measured with standardized cephalometric angular measurements

  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)

    Time frame: At baseline and at the end of treatment at 24 months

    Assessment of upper airway dimensions

  3. 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 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

  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

    Time frame: DISE is performed before treatment.

    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

  5. 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

    Measured with standardized cephalometric angular measurements

  6. 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

    Assessment of upper airway dimensions

  7. 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 DC/TMD is applied using both patient-reported symptom questionnaires and a structured clinical examination

  8. 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

    Dental occlusion assessed by intraoral scans and number of dental contacts in intercuspidal position (ICP)

  9. 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

    Measured in newtons (N)

  10. 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 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

  11. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Hartogsohn, PhD Student

CONTACT

[email protected]

+4535321136

Liselotte Sonnesen, Professor

CONTACT

[email protected]

+4535326670

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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