The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.
Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.
Provide signed and dated informed consent
Males or females aged 18 and above
Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
Previous surgery on the upper airways
None
Crossover
Polygraphy
Diagnostic testPolygraphy will be caried out at the patients home to evaluate each MRA after 3 monhts
Questionaire
Other interventionEpworth Sleepiness Scale o Johns, Murray W. "A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale." Sleep, vol. 14, no. 6, 1991, pp. 540-545.
Questionaire
Other interventionPatient experience questionnaire o Ng, E.T., Perez-Garcia, A., en Lagravère-Vich, M.O. "Development and Initial Validation of a Questionnaire to Measure Patient Experience with Oral Appliance Therapy." Journal of Clinical Sleep Medicine, vol. 19, nr. 8, 1 aug. 2023, pp. 1437-1445. doi: 10.5664/jcsm.10562. PMID: 37082817; PMCID: PMC10394373
Question
Other interventionPatient final choice of preferred MRA
AHI
Improvement of AHI (apnea-hypopnea index), measured by polygraphy before treatment and after treatment with each MRA. The goal of the mandibular advancement device is to reduce the number of apneas and hypopneas per hour, apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing. This is measured by a polygraphy-test overnight at the patiënts home.
Peripheral oxygen saturation 1
Measured by polygraphy * Average saturation (measured in %) * Lowest saturation (measured in %) Oxygen saturation in percent is the fraction of oxygen-saturated haemoglobin relative to total haemoglobin (unsaturated + saturated) in the blood \* 100%
Peripheral oxygen saturation 2
Measured by polygraphy o Oxygen desaturation index \>3% (events/h) Desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% for more than 10 seconds per hour
Peripheral oxygen saturation 3
Measured by polygraphy o Total duration with saturation \< 90% The percentage of cumulative time with oxygen saturation below 90% in total sleep time.
ESS
Epworth Sleepiness Scale (questionaire) The minimum value is 0 and the maximum value is 24. A higher score means a worse outcome, indicating more excessive daytime sleepiness. The Epworth Sleepiness Scale is scored by adding up the individual scores for each of the eight questions. Each question is rated on a scale of 0 to 3, with 0 being "no chance of dozing" and 3 being "high chance of dozing." ter daytime sleepiness. Score range Interpretation 0-5 Lower normal daytime sleepiness 6-10 Normal daytime sleepiness 11-12 Mild excessive daytime sleepiness 13-15 Moderate excessive daytime sleepiness 16-24 Severe excessive daytime sleepiness
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
