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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obstructief slaapapneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
n.a.
Background summary
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 manually 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 in not 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.
Study objective
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.
Study design
Single-centre prospective study.
Study burden and risks
n.a.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
• 18 years and older
• Diagnosis of OSA confirmed by a PSG (AHI >= 5 events per hour)
• Planned to undergo a standard DISE procedure
• Ability to speak, read and write Dutch
Exclusion criteria
• Dental problems: dental status excluding fitting an oral appliance
• Central Sleep Apnea syndrome (> 50% of central apneas)
• Inability to provided informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66070.100.18 |
| OMON | NL-OMON25469 |