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

NCT07677332 | Not Yet Recruiting

• 1 other identifier: 102-11297/25-3000
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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)

Keywords

Obstructive sleep apnea; OSA; MAD; CPAP; Orthodontics

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  At baseline and at the end of treatment at 24 months

Study Arms (2)

MAD-group

EXPERIMENTAL

Group starting with the MAD treatment

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

CPAP-group

EXPERIMENTAL

Group starting with the CPAP treatment

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

Interventions

Mandibular advancement device (MAD) DEVICE

18 months of treatment with MAD in total.

CPAP-group; MAD-group

Continuous positive airway pressure (CPAP) DEVICE

6 months of treatment with CPAP in total.

CPAP-group; MAD-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Liselotte Sonnesen, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Hartogsohn, PhD Student

CONTACT

+4535321136; clara.hartogsohn@sund.ku.dk

Liselotte Sonnesen, Professor

CONTACT

+4535326670; alson@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator blinded to the DISE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)