Jaw thrust versus the use of a boil and bite mandibular advancement device as a screening tool during drug-induced sleep endoscopy.

Rationale: Mandibular advancement devices (MADs) are commonly used in patients with mild to moderate obstructive sleep apnea (OSA). However they have not a desired effect in all patients. In order to prevent upper airway obstructions, MADs are designed to advance the mandible in a forward position. During a drug-induced sleep endoscopy (DISE) a jaw thrust may be performed in order to predict the possible treatment outcome of MAD therapy. Unfortunately, this manoeuvre might not be representative for the in vitro effect of a MAD. Previous studies have evaluated several screening instruments, for example a thermoplastic appliance, but it was concluded that the effect of a thermoplastic appliance isnot similar to the effect of a custom made MAD. Also the use of a simulation bite during DISE has been proposed and although it was concluded to be successful, the use of these devices is highly time consuming. Since then, new simulation bites have been developed. To predict and improve treatment success, a boil and bite MAD could be a relative cheap, quick and an easy to use system to mimic the effect of a MAD during DISE and is of interest in research settings and habituation. One of these devices is the MyTAP.

Objective: This will be the first part of two-part study. The aim of this first study is to compare the effect of manually performed jaw thrust with the effect of the boil and bite MAD, MyTAP, during DISE by using the VOTE classification. The second part of the study will be described in a separate protocol.

Study design: Single-centre prospective study.

Study population: Patients aged 18 year or older diagnosed with OSA confirmed by polysomnography who will be evaluated during a standard DISE. DISE will be assessed in supine and non-supine position with and without manually performed jaw thrust.

Intervention: DISE will be assessed in supine and non-supine position with the MyTAP in situ.

Main study parameters/endpoints: The degree of upper airway collapse during DISE according to the VOTE classification system in non-supine and supine position, with and without jaw thrust and the MyTAP in situ.

Sample size: 100 participants

The aim of this study is to compare the effect of two screening instruments, a manually performed jaw thrust and a boil and bite MAD (MyTAP), on upper airway patency during DISE according to the VOTE classification system. We hypothesize that the effect on upper airway patency during DISE of a manually performed jaw thrust is not similar compared to the effect of a boil and bite MAD (MyTAP).

The intervention will take place during drug-induced sleep endoscopy (DISE) in an outpatient clinic setting.

Patients will undergo DISE as usual with additional assessment of the upper airway with the MyTAP in situ. The MyTAP is a thermoplastic mandibular advancement device (MAD) which can be used as a transitional oral appliance in the treatment of OSA.