To our best knowledge, there are no studies on the preference of OSA patients for one or another MAD type based on its design characteristics. Therefore, the main objective of the study is to compare these MADs on the aspect of preference of…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
Slaapstoornissen, slaapapneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of this study is to compare the Narval CC® and the SomnoDent Flex® in a
short-term and long-term follow-up. The primary outcome measures in the
short-term and long-term follow-up are:
Short-term follow-up:
Primary outcome measure:
1. Preferred MAD: outcome based on a questionnaire on preference.
Long-term follow-up:
Primary outcome measure:
1. Mean disease alleviation: the product of sleep-time adjusted adherence
(subjective oral appliance (OA) use/total sleep time, expressed in percentage)
with therapeutic MAD efficacy (AHI baseline minus AHI with OA applied,
expressed in percentage), divided by 100.
Secondary outcome
The aim of this study is to compare the Narval CC® and the SomnoDent Flex® in a
short-term and long-term follow-up. The secondary outcome measures in the
short-term and long-term follow-up are:
Short-term follow-up:
Secondary outcome measures:
1. Adherence: self-reported number of hours of wearing the MAD per total sleep
time, in hours, *100%.
2. Therapy success: the number of patients with an apnea-hypopnea index (AHI)
of <5 events/hour of sleep.
3. Quality of life and sleep quality: total score of quality of life
questionnaire and that of sleep quality questionnaire.
4. Mean disease alleviation: the product of sleep-time adjusted adherence
(subjective oral appliance (OA) use/total sleep time, expressed in percentage)
with therapeutic MAD efficacy (i.e., AHI baseline minus AHI with OA applied,
expressed in percentage), divided by 100.
5. Side-effects: number and type of side-effects.
6. Clinical performance: number of unexpected visits to the outpatient clinic
for their MAD therapy.
Long-term follow-up:
Secondary outcome measures:
1. Adherence: self-reported number of hours of wearing the MAD per total sleep
time, in hours *100%
2. Therapy success: the number of patients with an AHI of <5 events/hour of
sleep
3. Quality of life and sleep quality: total score of quality of life
questionnaire and that of sleep quality questionnaire.
4. Orthodontic side-effects: overbite (i.e., it refers to the vertical overlap
between the maxillary central incisors over the mandibular central incisors)
and overjet (i.e., it refers to the horizontal overlap of the maxillary central
incisors over the mandibular central incisors), in mm
5. Clinical performance: number of unexpected visits to the outpatient clinic
for their MAD therapy
6. Costs: the estimated mean total costs in EUR per MAD during study (e.g.,
chair time of each visit, production costs of MAD, costs of reparations,
consult time by phone)
Background summary
Obstructive Sleep Apnea (OSA) is a condition characterized by repetitive
complete or partial obstructions of the upper airway that are often related to
oxygen desaturations and arousals from sleep. The prevalence of OSA varies from
9% to 38% in the general adult population, affecting more men than women,
primarily in middle-aged, obese individuals. Mandibular advancement devices
(MADs) are commonly prescribed for the treatment of mild to moderate OSA
patients, and for severe OSA patients who cannot tolerate continuous positive
airway pressure (CPAP). The rationale behind the efficacy of MADs is that
advancement of the mandible and tongue improves upper airway patency during
sleep by enlarging the upper airway and by decreasing upper airway
collapsibility, thereby preventing collapse during sleep.
In this study, Narval CC® (ResMed, Lyon, France) and SomnoDent Flex® (SomnoMed,
Sydney, Australia) MADs are compared in OSA patients. The main differences in
design between these MADs are: 1. the size, weight, and material, which could
influence the preference of patients and their adherence to the therapy; and 2.
the couple-mechanism between upper and lower splints, which could result in
differences in the appliances* effects on OSA.
Study objective
To our best knowledge, there are no studies on the preference of OSA patients
for one or another MAD type based on its design characteristics. Therefore, the
main objective of the study is to compare these MADs on the aspect of
preference of patients based on the design characteristics of the MAD. The
secondary objectives of this study are to compare these MADs on adherence,
therapy success, quality of life, mean disease alleviation (MDA), side-effects,
clinical performance, and costs.
Study design
Randomized crossover design
Intervention
This study focuses on preference of OSA patients for one or another MAD type by
comparing two different types of MADs in a randomized crossover design. The
first type is the Narval CC® (ResMed, Lyon, France), which is manufactured by
computer-aided design-computer-aided manufacturing (CAD-CAM) technology. The
Narval CC®-MAD consists of two splints, fixed on the mandible and the maxilla,
and connected to each other with replaceable bars of different lengths for
titration (i.e., the MAD gradually places the mandible in a more anterior
position for an optimal therapeutic result).The vertical opening is limited by
these bars. The second type is the SomnoDent Flex® (SomnoMed, Sydney,
Australia), which consists of two splints, fixed on the mandible and the
maxilla and allowing free vertical opening. It has a screw mechanism in the
upper splint, which is used for titration. The SomnoDent Flex® is manufactured
by conventional technology. The impressions will be send to a dental technician
and will be used to make a custom-made MAD manually.
Study burden and risks
The risks for patients participating in this study are negligible. Possible
common short-term side effects of both MADs may be discomfort in the jaw,
temporomandibular joint pain, sensitivity of the teeth, excessive salivation
and a dry mouth. Withdrawing from this therapy means an immediate relief of
inconveniences in case of the short-term effects. A common long-term
side-effect is orthodontic tooth movement. These orthodontic tooth movements
are small in the majority of the cases.
As part of their standard care, the patients will undergo an orthopantomogram
(OPT) at baseline before the start of MAD treatment. The OPT is made to check
if the dentition is adequate for manufacturing an MAD. This OPT is not used for
research purposes. To determine the orthodontic side effects on skeletal level
(i.e., to compare the lateral cephalogram at different moments during the
course of the treatment with the MAD, and to evaluate orthodontic tooth
movement), patients will undergo a lateral cephalogram examination at baseline,
at one-year follow up, and at five-year follow up. Both OPT and lateral
cephalogram involve the use of radiation and therefore the application of the
standard principles for the safe use of radiation is needed. The effective dose
of an OPT is about 20µSv; for a lateral cephalogram, about 7µSv. The total
effective dose for patients in this study is (1x 20) + (4 x 7) = 48µSv. 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 [1] (Appendix 1). Our study belongs to category I, which involves
risks of 10-6 or less. The risks include cancer and hereditary disorders [2].
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 according to the ICRP categories.
Gustav Mahlerlaan 3004
AMSTERDAM 1081LA
NL
Gustav Mahlerlaan 3004
AMSTERDAM 1081LA
NL
Listed location countries
Age
Inclusion criteria
• 18 years or older;
• Sufficient understanding of Dutch language in speaking, reading, and writing;
• 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).
• Dentition is adequate for both MADs (e.g., normal dental crown height, normal
dental arch)
Exclusion criteria
• Reversible morphological upper airway abnormalities (e.g. enlarged tonsils);
• Previous treatment with an MAD;
• Inability to provide informed consent;
• Simultaneous use of other modalities to treat OSA;
• Known medical history of mental retardation, memory disorders, or psychiatric
disorders;
• Evidence of respiratory/sleep disorders other than OSA (e.g., central sleep
apnea (CSA));
• Medication usage that has an effect on sleep;
• Untreated periodontal problems, dental pain, and a lack of retention
possibilities for both MADs;
• Severe temporomandibular disorders (based on the function examination of the
masticatory system).
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 | NL77762.075.22 |