Obstructive Sleep Apnea Mandibular Advancement Thearpy
Conditions
Interventions
Patients will visit the hospital where the three measurements will be performed. Before the measurements are performed, the demographic data is obtained. The measurements are divided into three differ
Sponsors
Medisch Spectrum Twente
Postbus 50 000
7500 KA Enschede
053 487 20 00
Eligibility
Inclusion criteria
Inclusion criteria: Obstructive Sleep Apnea (OSAS) patients with an age of ≥ 18 years. Apnoea-hypopnoea index (AHI) ≥ 15 Signed informed consent prior to participation. Scheduled a control poly(somno)graph after titration of mandibular advancement device (MAD) therapy.
Exclusion criteria
Exclusion criteria: Inability to read and/or understand the Dutch language. Having a control polygraph after an initial polysomnography Having a control polysomnography after an initial polygraph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy, expressed as sensitivity, specificity, negative predictive value and positive predictive value, for the different measurement parameters. The parameters of the different measurements are: - Spirometry: absolute difference between the ratios of the expiratory flow rate at 50% of vital capacity to the inspiratory flow rate at 50% of vital capacity (MEF50:MIF50) obtained by the MAD in maximal retracted and maximal protrusive position. - FOT: absolute difference between the mid-frequency resistances (R20) obtained by the MAD in maximal retracted and maximal protrusive position. - NEP: absolute difference in flow drops (ΔV ̇) as a percentage of the peak flows (%Vpeak) obtained by the MAD in maximal retracted and maximal protrusive position. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The diagnostic accuracy of the different primary measurement parameters with the relative differences instead of the absolute differences between the prediction of MAD success. - The experience of the subjects with the different tests. This will be evaluated with three questions. - The diagnostic accuracy of the other spirometry parameters (FVC, FIVC, FIV1, FEV1, ‘saw toothing’, MEF50, MIF50, VC) for successful MAD therapy, by both calculating the absolute and relative differences between the results obtained by a MAD in maximal retracted and maximal protrusive position. - The diagnostic accuracy of the other FOT parameters (R5, X5, R5-20, fres, AX) for successful MAD therapy, by both calculating the absolute and relative differences between the results obtained by a MAD in maximal retracted and maximal protrusive position. - The diagnostic accuracy of the V0.2 of the NEP measurement as a percentage of the mean inspiratory volume of the 3 breaths preceding NEP and as a percentage of the mean expiratory volume during the first 0.2 s of the 3 breaths preceding NEP for successful MAD therapy. This is performed by both calculating the absolute and relative differences between the results obtained by a MAD in maximal retracted and maximal protrusive position. - The diagnostic accuracy of the percentage of expired tidal volume over which the NEP-induced flow did not exceed spontaneous flow (%EFL) for successful MAD therapy, by both calculating the absolute and relative differences between the results obtained by a MAD in maximal retracted and maximal protrusive position. - Additional study parameters are obtained by performing an explorable analysis on the spirometry, FOT and NEP data. The diagnostic accuracy of these parameters as for successful MAD therapy are determined by both calculating the absolute and relative differences between the results obtained by the mandible maximal retracted and maximal protruded. - The diagnostic accuracy of the different p | — |
Contacts
Public ContactGerike Buitenhuis
Medisch Spectrum Twente
Outcome results
None listed