To compare the effect of two different types of mandibular advancement device (MAD) on polysomnographic (PSG) parameters, to evaluate the compliance and to evaluate the outcome of the different Quality of Life scales, eg general health with the…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints: reduction of PSG parameters, in particular Apnoea Hypopnoea
Index (AHI), Apnoea Index (AI), Hypopnoea Index (HI), Desaturation Index (DI),
and sleep efficiency at baseline, 3 months, and 1 year.
Addendum CBCT:
Primary endpoint: minimum cross-sectional area (CSAmin); mandibular length
(me-go).
Secondary outcome
Secondary endpoints: outcome of Quality of Life (QoL) questionnaires; the QoL
is measured with questionnaires regarding general health (EQUOL), sleep health
and daily functioning (AMCSQ, ESS, FOSQ), and functionality of the dentition
and jaws (RDC/TMD and MFIQ) at baseline, 3, 6, 9 and 12 months. Compliance will
also be evaluated for the time period of 3, 6, 9 and 12 months
Addendum CBCT:
Secondary endpoints are upper airway size: anterior-posterior (AP) and lateral
(L) dimensions of the CSAmin, and the volume of the upper airway (V); upper
airway shape: 2-D shape of the upper airway (AP/L); and 3-D shape of the upper
airway (CSAmin / CSAavg); face width (tl-tr), anterior neck space area
(ste-cr-ty-cer-me), and cervicomental angle (np-cer-me).
Background summary
Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often
requires lifelong care. The prevalence in the Netherlands is estimated around
300.000 patients. Due to longer life expectancy and increase in weight in the
general population, its prevalence is expected to rise. Patients with mild and
moderate OSA are treated primarily with an oral appliance at present time.
Different oral appliances are available, but most used is the mandibular
advancement device (MAD). This study focuses on two different types of MAD: the
classic Herbst appliance, which is attached to the mandible and the maxilla and
has an iron bar to regulate the open space; and the Somnodent, which consists
of two separate splints, fixed on the mandible and the maxilla, but has no iron
bar attached.
Addendum CBCT:
Recently, the use of cone beam computed tomography (CBCT) in dentistry has
increased considerably. Its high spatial resolution between soft tissue and
empty space and its low radiation dose make it an unprecedented method to
analyse the upper airway anatomy three-dimensionally. The understanding of the
exact working mechanisms of different MADs remains limited. It was suggested
that the pattern and magnitude of changes in upper airway anatomy may differ
between oral appliances, but more solid data is needed to draw this conclusion.
Therefore, large prospective randomized controlled studies are needed to
provide more insight into the working mechanisms of different MADs.
Study objective
To compare the effect of two different types of mandibular advancement device
(MAD) on polysomnographic (PSG) parameters, to evaluate the compliance and to
evaluate the outcome of the different Quality of Life scales, eg general health
with the Equol, daytime sleepiness (symptoms) with the Epworth Sleeping Scale
(ESS), Functional Outcome of Sleep Questionnaire (FOSQ), jaw pain and function
(RDC/TMD and MFIQ) and daily functioning with MAD (OACS)
Addendum CBCT:
The second objective is to determine the difference between *Somnodent* and
*Herbst* in their effects on the upper airway morphology.
The third objective is to determine the difference between responders and
non-responders to MADs in upper airway anatomy and external craniofacial
anatomy at baseline.
Study design
Randomised controlled trial
Intervention
For mild and moderate OSA, the treatment with a MAD is standard therapy. MAD is
an intra-oral prosthesis, which holds the mandible in a protrusive position.
Because of this position, more pharyngeal space will be available and the AHI
(Apnea-Hypopnea-Index) will decrease. Different types of MAD are available, and
further research is needed before the physician can make a choice between the
different types. In this study, the Somnodent MAD will be evaluated in a RCT
with the Herbst appliance. After randomisation, the patient will be allocated
to one of the two groups. After 3 months and after 1 year, a PSG is repeated.
Addendum CBCT:
At baseline and after 3 months, CBCT scans will be made at the department of
Oral Radiology at ACTA (at baseline without MADs in situ, and after 3 months
with MADs in situ). Photographs will be made at baseline at our clinic.
Study burden and risks
The risks for patients participating in this study are negligible. Possible
side effects of MAD (Somnodent and Herbst) may be discomfort in the jaw,
sensitivity of the teeth, and a dry mouth. Withdrawing from this therapy means
immediate relief of inconveniences.
Addendum CBCT:
For NewTom CBCT, the effective doses for large FOVs range from 30~78 µSv, about
50 µSv on average. The International Commission on Radiological Protection
(ICRP) 62 has categorized research into four levels, depending upon the
radiation dose to be received by each subject. This study belongs to category
I, which involves risks of 10-6 or less. Besides, compared with the average
risk of cancer and hereditary disorders of the population (1/17,000 and
1/77,000 respectively), the risk in this study is minor and could be neglected.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
+ 18 years and older
+ Ability to speak, read, and write Dutch.
+ Ability to follow-up.
+ Ability to use a computer with internet connection for online questionnaires.
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Expected to maintain current lifestyle (sports, medicine, diet, etc.)
Exclusion criteria
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- Medication used/related to sleeping disorders.
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- Temporomandibular disorders (based on the function examination of the masticatory system).
- Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, PLMS, Narcolepsy).
- Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- simultaneous use of other modalities to treat OSA.
- Previous treatment with a MAD.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44085.018.13 |