The aim of this study is to evaluate whether the MyTAP can be used as a screening tool to predict treatment success with MAD therapy. This will be evaluated during a 3 month follow-up of the therapy.Secondly, we want to compare the patient…
ID
Source
Brief title
Condition
- Other condition
- Upper respiratory tract disorders (excl infections)
Synonym
Health condition
obstructief slaapapneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Polysomnographic parameters (total AHI, supine AHI, non-supine AHI, ODI)
Secondary outcome
OSAsense S18 parameters (ODI)
Outcome of Quality of Life questionnaires;
- Epworth Sleepiness Scale
- Functional Outcome of Sleep Questionnaire
- Short Form Health Survey
Mandibular advancement
Compliance and treatment satisfactionAdverse Events
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 is performed in order to predict the possible treatment
outcome of MAD therapy. Unfortunately, this manoeuvre might not be
representative for the real life effect of a MAD. The use of a simulation bite
during DISE has been proposed, but scientific evidence is minimal and new
simulation bites are developed. To predict and improve treatment success, a
boil and bite simulation bite is a cheap, quick and might be an easy to use
system to mimic the effect of a MAD during DISE and is of interest in research
settings and habituation. In the METc protocol ABR 66070 the MyTAP is used as a
screening tool and compared to the jaw thrust during DISE. The aim of the
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. 200 patients aged 18 year or older diagnosed with OSA confirmed
by a type II polysomnography will be included in this single-centre prospective
study. DISE will be assessed three times: with and without manually performed
jaw thrust and with the MyTAP in situ.
The MyTAP is a new thermoplastic boil and bite MAD which can also be used as a
transitional oral appliance in the treatment of OSA. The devise can be easily
fitted within 15 minutes. This allows patients to begin treatment directly and
experience the benefits and possible disadvantages of MAD treatment. Besides
the MyTAP is an efficient and cost-effective way to find out if MAD treatment
is suitable for the patient.
Study objective
The aim of this study is to evaluate whether the MyTAP can be used as a
screening tool to predict treatment success with MAD therapy. This will be
evaluated during a 3 month follow-up of the therapy.
Secondly, we want to compare the patient compliance and satisfaction of the
MyTAP to a custom-made MAD during a follow-up period of 3 months. In addition
we want to compare the polysomnographyic outcomes to the OSAsense S18 outcomes
to evaluate if the OSAsense S18 is a good treatment evaluater.
Finally PSG outcomes of boil and bite MAD and curstom MAD will be compared with
DISE outcomes to evaluate wheather DISE is a good screening tool for MAD
therapy and wheather the MyTAP can be used as a screening tool during DISE to
predict treatment success with MAD therapy.
Study design
Single-centre prospective cross-over study.
Intervention
58 consecutive OSAS patients will be included in a crossover design and
selected for treatment with a custom MAD and a boil and bite MAD. Both
interventions are used for a period of 3 months with a washout of 1 week. After
each period of 3 months a PSG, wrist oximetry and secondary questionnaires are
performed.
Study burden and risks
Possible risks or side-effects MAD treatment on short term:
- Hypo or hyper salivation
- tooth pain
- sensitive gums
- temporomandibular joint pain or myofacial pain
- small dental changes
- tooth damage
small risk with negligible damage
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
Inclusion criteria
* OSA patient confirmed by a PSG
* 18 years and older
* Sufficient understanding of Dutch language in speaking and writing
* Included in DISE study with METc protocol ARB 66070, NL66070.100.18
Exclusion criteria
Medical and psychological criteria:
* Clear failure or non-acceptance of previous MAD therapy
* Central Sleep Apnea syndrome ( > 50% of central apneas)
* Inability to provided informed consent
* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils),
Dental criteria:
* Extensive periodontal disease or tooth decay (confirmed by Xray).
* Active temporomandibular joint disease (including severe bruxism).
* Restrictions in mouth opening (<25 mm) or advancement of the mandible (<5 mm).
* Partial or complete edentulism (less than 8 teeth in upper or lower jaw).
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 | NL64738.100.18 |
| OMON | NL-OMON28622 |