The difference in resistance and flow parameters obtained by spirometry, forced oscillation technique (FOT) and negative expiratory pressure (NEP) in protrusion and retraction of the mandible in OSAS patients are predictive parameters for successful…
ID
Bron
Verkorte titel
Aandoening
Obstructive Sleep Apnea
Mandibular Advancement Thearpy
Ondersteuning
Postbus 50 000
7500 KA Enschede
053 487 20 00
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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: <br>
- 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.<br>
- FOT: absolute difference between the mid-frequency resistances (R20) obtained by the MAD in maximal retracted and maximal protrusive position.<br>
- 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.
Achtergrond van het onderzoek
In this study, 25 patients with obstructive sleep apnea (OSAS) are included. An adjustable mouthpiece will be applied during three different pulmonary function tests: a spirometry, a forced oscillation technique (FOT) and a negative expiratory pressure (NEP). The measurements are performed twice while the subject is lying on his/her back; with the mandible completely protruded and with the mandible completely retracted. The main study objective is to investigate the diagnostic accuracy, expressed as the sensitivity, specificity, negative predictive value and positive predictive value of resistance and flow parameters obtained by spirometry, FOT, and NEP both in protrusion and retraction of the mandible in OSAS patients for the prediction of successful MAD therapy compared to a poly(somno)graph
Doel van het onderzoek
The difference in resistance and flow parameters obtained by spirometry, forced oscillation technique (FOT) and negative expiratory pressure (NEP) in protrusion and retraction of the mandible in OSAS patients are predictive parameters for successful mandibular advancement device (MAD) therapy.
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
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 different measurements: the forced oscillation technique (FOT), negative expiratory pressure (NEP) and the spirometry. During the measurements the patients is wearing an adjustable mouthpiece to enable protrusion and retraction of the mandible. All the measurements are perfored with the mandible in the maximal comfortable retracted and maximal comfortable protrusive position. The measurements are performed while the patient is laying on his back on a flat examination bench with the legs uncrossed. After the three different measurements in lying position, a standard spirometry in sitting position is performed. The vital capacity is measured and also the forced vital capacity during a forced maximal inspiration and expiration. At the end the patient is asked to answer some questions to evaluate their experience with the different measurements.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL7441 |
NTR-old | NTR7683 |
CCMO | NL67820.044.18 |
OMON | NL-OMON48021 |