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

Condition(s) studied

Investigational drug(s) / intervention(s)

Mandibular advancement device (MAD): 18 months of treatment with MAD in total.

Continuous positive airway pressure (CPAP): 6 months of treatment with CPAP in total.

Study 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.

Eligibility

Primary outcome measure(s)

• Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI) — 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) — 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 — 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) — 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) — 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) — 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) — 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

Trial sites (1)

More University of Copenhagen trials in Denmark

Other trials for the same condition