Apnea SyndromeSONARNCT04474756
Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) During Sleep
A study testing custom-made adjustable mandibular advancement device in people with Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea Syndrome
- What is being tested?
- custom-made adjustable mandibular advancement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent before participation
- Age ≥18 years
- Moderate to severe OSA defined by:
- AHI ≥30 or,
- 15≤ AHI <30, but associated with excessive daytime sleepiness or,
- 15≤ AHI <30, with at least two of the following criteria not explained by other factors: severe and daily snoring, choking or suffocating sensation during sleep, non-restorative sleep, daytime fatigue, difficulty concentrating, nocturia (more than one urination per night).
- Naïve from any mandibular advancement device
- Patient affiliated to a social security/health insurance system
Who cannot join
- One or more of the following contra-indications:
- dental problems (tooth failure, poor distribution or insufficient dental retention)
- periodontal problems: active periodontitis not stabilized. Presence of periodontal pockets, advanced bone loss, significant tooth mobility, insufficient dental plaque control.
- temporomandibular joint disorder (TJD)
- maximum mandibular propulsion distance limited (< 6 mm)
- More than 20% of central apnea and hypopnea
Show all 13Show fewer
- Severe psychiatric or neuromuscular disorder
- Body Mass Index (BMI) > 30 kg/m2
- Current orthodontic treatment or planned during the study
- Pregnant women based on clinical exam and medical questioning.
- Subject in exclusion period of another interventional study
- Subject under administrative or judicial control
- Subject unable to understand, follow objectives or methods due to cognition or language problems
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, Isère, 38700
Renaud TAMISIER, MD, PhD, +33(0)4 76 76 84 69, RTamisier@chu-grenoble.fr
Marie PEETERS, +33(0)4 76 76 92 65, MPeeters@chu-grenoble.fr
About this study
Official title: Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep
Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).
Read the detailed description
Obstructive Sleep Apnea (OSA) is characterized by repetitive episodes of partial or complete pharyngeal obstruction during sleep. OSA is one of the most frequent chronic diseases with both social and multi-organ consequences making it an economic burden for society. OSA durably impairs the quality of life of patients and their entourage and is associated with co-morbidities including hypertension, arrhythmias, stroke, coronary heart disease and metabolic dysfunction.
Continuous positive airway pressure (CPAP), the first line therapy for OSA, requires high adherence to be effective in terms of symptom improvement and reduction of the burden of co-morbidities. For one third of patients, such adherence is difficult to achieve in the long term and mandibular advancement devices (MAD) have emerged as the leading alternative to CPAP. So, MADs are now a reliable alternative to CPAP treatments, which position these in numerous patients as a first therapy. Moreover, mild to moderate symptomatic patients who refuse to be diagnosed are now referring to sleep centers in order to be treated. MAD and CPAP are similarly effective on symptoms, quality of life and in attaining reductions in blood pressure and cardiovascular morbidity. Although CPAP has a greater effect on Apnea + hypopnea index (AHI) reduction, adherence is better with MAD explaining the comparable mean disease alleviation achieved by the two treatment modalities.
Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various different MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Titratable two-piece custom-made MADs are the gold standard in clinical guidelines and several brands are now on the market. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. Such a paradigm merits being tested in a randomized controlled trial. The SONAR study is a multicenter, parallel-group randomized controlled trial to determine if the titratable MAD NARVAL TM is superior to the titratable MAD TALITM in OSA patients eligible for MAD. The primary outcome will be the treatment response at 3 months assessed by the difference of delta AHI at baseline and follow-up measured by polysomnography and secondary outcomes focus at global efficacy, tolerance and patient satisfaction.
To our knowledge it will be the first study comparing two titrable MADs.
- Conditions
- Apnea Syndrome
- Being tested
- custom-made adjustable mandibular advancement device
- Keywords
- Obstructive Sleep Apnea, mandibular advancement devices, Mandibular movement, Polysomnography
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom-made adjustable mandibular advancement deviceDevice
Also called mandibular advancement orthosis (MAD)
a custom-made mandibular repositioning device (MRD), available under medical prescription for the treatment of adult obstructive sleep apnea (OSA) and snoring. It maintains the mandible in an advanced position along the occlusal plane. This ensures patient comfort and treatment efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Advancement Devices Narval™ | Experimental | The tested device Narval™ will be a custom-made adjustable bi-block mandibular advancement device, that is made with semi-rigid plastic materials (bio-compatible polymer) and customized using a high-precision computer-aided design (CAD)/computer-aided manufacturing (CAM) ) (ResMed, Narval CC™). The Mandibular Advancement Devices will be gradually adjusted to provide mandibular advancement over a 15-mm range. Each Mandibular Advancement Device will be fitted by a dental specialist with an initial advancement of about 60 % of maximal jaw protrusion. During titration, mandibular advancement will be adjusted at the discretion of the dental specialist. Receives: Device: custom-made adjustable mandibular advancement device |
| Mandibular Advancement Devices TALI ™ | Active comparator | The control device TALI ™ is a mandibular advancement orthesis, customized and manufactured by the "laboratoire TALI", of the bi-bloc type consisting of rigid gutters thermo-formed on the plaster dental arches and articulated by two links of variable size allowing to adjust the advance in steps of 1 millimeter. This orthesis is manufactured on molding from bio-compatible plastic materials. The different sizes of rods proposed allow mandibular advances of 4 mm to 16 mm. Two clinical studies evaluated the effectiveness of the AMC / AMO orthosis (initial version of the TALI orthesis, with non-curved links) in patients with OSA. They have already demonstrated the effectiveness of the TALI orthesis by decreasing AHI and drowsiness; most patients preferred to use the orthesis (76.4% vs. 9.1%)11. Receives: Device: custom-made adjustable mandibular advancement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of efficacy of two Mandibular Advancement Devices: NarvalTM and TALITM
The difference of effectiveness between Mandibular Advancement Devices will be assessed using the difference of delta AHI, measured by Polysomnography, between the visit 2 (M3) and the Polysomnography before Mandibular Advancement Devices installation.
Measured: at the end of the 3-month period
Secondary outcomes (9)
To compare the efficacy of titration with each Mandibular Advancement Devices
Delay of titration period, number of additional titration visits required
Measured: between the oral appliance delivery and the end of the titration period at 3 months
To compare the number of patients appropriately treated by Mandibular Advancement Devices between the two devices
Rate of complete response (AHI<10) or partial response (AHI<15) of treatment:
The percentage of patients with AHI <15, or ≥ 50% reduction in AHI from baseline (D0) to D90 (3 months), associated with a subjective (patient reported) compliance ≥ 5 nights/week and 5 hours/night. AHI assessed by polysomnography
Measured: after 3 months of treatment with mandibular advancement device
To compare the tolerance in the 2 arms
Rate of side effects, jaw discomfort (visual analogic scale) scale), mean number of hours by night wearing the mandibular device (patient diary), therapy withdrawals
Measured: after 3 months of treatment
To compare the sleep quality
RDI, total sleep time, TST, PST, Sleep latency, WASO, Sleep efficiency, Time in stage I, II, SWS and REM sleep respectively, Total micro-arousals, respiratory micro-arousals and PLM micro-arousals, assessed by Polysomnography.
Measured: after 3 months of treatment with mandibular advancement device
To compare the mandible behavior (mandibular movement (MM)) during sleep) with each Mandibular Advancement Device
Mandibular movement, RDI and time spent in respiratory effort, assessed by home-based recording (by Class IIA polygraphic device: Sunrise® Solution with mandibular movement recording), and mandibular movement recording by Jaw-ac technology, added to the classical procedure (Polysomnography)
Measured: after 1 month and 3 month of treatment with each Mandibular Advancement Device
To compare the evolution of obstructive sleep apnea associated subjective daytime sleepiness with each Mandibular Advancement Device
by Epworth sleepiness score
Measured: after 3 months of treatment with each Mandibular Advancement Device
To compare subjective snoring perception by the patient's environment
by subjective snoring (visual analogic scale-VAS)
Measured: after 3 months of treatment with each Mandibular Advancement Device
To compare patient satisfaction
using the Questionnaire VSQ-VF
Measured: after 3 months of treatment with mandibular advancement device
To compare the effect of obstructive sleep apnea on patient's quality of life
by Quebec Quality of life questionnaire
Measured: after 3 months of treatment with each Mandibular Advancement Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Jun 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, comparative, open, multicenter study. 90 patients, randomized into two parallel groups, comparing the efficacy of 2 different custom-made mandibular advancement devices: NarvalTM versus TALITM, in the treatment of obstructive sleep apnea (OSA).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud TAMISIER, MD, PhD, Principal investigator, Grenoble University Hospital, La Tronche 38700, France,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474756
- Sponsor's protocol ID
- 2019-A01714-53
- Acronym
- SONAR
- Status last verified
- Jul 2020
- First submitted
- 26 Dec 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep
- ClinicalTrials.gov ID
- NCT04474756
- Acronym / sponsor ID
- SONAR / 2019-A01714-53
- Conditions
- Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea, mandibular advancement devices, Mandibular movement, Polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).
Detailed description
Obstructive Sleep Apnea (OSA) is characterized by repetitive episodes of partial or complete pharyngeal obstruction during sleep. OSA is one of the most frequent chronic diseases with both social and multi-organ consequences making it an economic burden for society. OSA durably impairs the quality of life of patients and their entourage and is associated with co-morbidities including hypertension, arrhythmias, stroke, coronary heart disease and metabolic dysfunction.
Continuous positive airway pressure (CPAP), the first line therapy for OSA, requires high adherence to be effective in terms of symptom improvement and reduction of the burden of co-morbidities. For one third of patients, such adherence is difficult to achieve in the long term and mandibular advancement devices (MAD) have emerged as the leading alternative to CPAP. So, MADs are now a reliable alternative to CPAP treatments, which position these in numerous patients as a first therapy. Moreover, mild to moderate symptomatic patients who refuse to be diagnosed are now referring to sleep centers in order to be treated. MAD and CPAP are similarly effective on symptoms, quality of life and in attaining reductions in blood pressure and cardiovascular morbidity. Although CPAP has a greater effect on Apnea + hypopnea index (AHI) reduction, adherence is better with MAD explaining the comparable mean disease alleviation achieved by the two treatment modalities.
Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various different MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Titratable two-piece custom-made MADs are the gold standard in clinical guidelines and several brands are now on the market. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. Such a paradigm merits being tested in a randomized controlled trial. The SONAR study is a multicenter, parallel-group randomized controlled trial to determine if the titratable MAD NARVAL TM is superior to the titratable MAD TALITM in OSA patients eligible for MAD. The primary outcome will be the treatment response at 3 months assessed by the difference of delta AHI at baseline and follow-up measured by polysomnography and secondary outcomes focus at global efficacy, tolerance and patient satisfaction.
To our knowledge it will be the first study comparing two titrable MADs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, comparative, open, multicenter study. 90 patients, randomized into two parallel groups, comparing the efficacy of 2 different custom-made mandibular advancement devices: NarvalTM versus TALITM, in the treatment of obstructive sleep apnea (OSA).
| Arm | Type | Receives |
|---|---|---|
| Mandibular Advancement Devices Narval™ | Experimental | Device: custom-made adjustable mandibular advancement deviceThe tested device Narval™ will be a custom-made adjustable bi-block mandibular advancement device, that is made with semi-rigid plastic materials (bio-compatible polymer) and customized using a high-precision computer-aided design (CAD)/computer-aided manufacturing (CAM) ) (ResMed, Narval CC™). The Mandibular Advancement Devices will be gradually adjusted to provide mandibular advancement over a 15-mm range. Each Mandibular Advancement Device will be fitted by a dental specialist with an initial advancement of about 60 % of maximal jaw protrusion. During titration, mandibular advancement will be adjusted at the discretion of the dental specialist. |
| Mandibular Advancement Devices TALI ™ | Active comparator | Device: custom-made adjustable mandibular advancement deviceThe control device TALI ™ is a mandibular advancement orthesis, customized and manufactured by the "laboratoire TALI", of the bi-bloc type consisting of rigid gutters thermo-formed on the plaster dental arches and articulated by two links of variable size allowing to adjust the advance in steps of 1 millimeter. This orthesis is manufactured on molding from bio-compatible plastic materials. The different sizes of rods proposed allow mandibular advances of 4 mm to 16 mm. Two clinical studies evaluated the effectiveness of the AMC / AMO orthosis (initial version of the TALI orthesis, with non-curved links) in patients with OSA. They have already demonstrated the effectiveness of the TALI orthesis by decreasing AHI and drowsiness; most patients preferred to use the orthesis (76.4% vs. 9.1%)11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent before participation
- Age ≥18 years
- Moderate to severe OSA defined by:
- Naïve from any mandibular advancement device
- Patient affiliated to a social security/health insurance system
Key exclusion criteria (13 listed)
- One or more of the following contra-indications:
- More than 20% of central apnea and hypopnea
- Severe psychiatric or neuromuscular disorder
- Body Mass Index (BMI) > 30 kg/m2
- Current orthodontic treatment or planned during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom-made adjustable mandibular advancement deviceAlso: mandibular advancement orthosis (MAD)a custom-made mandibular repositioning device (MRD), available under medical prescription for the treatment of adult obstructive sleep apnea (OSA) and snoring. It maintains the mandible in an advanced position along the occlusal plane. This ensures patient comfort and treatment efficacy. | Device | Mandibular Advancement Devices Narval™, Mandibular Advancement Devices TALI ™ |
Primary outcome
Comparison of efficacy of two Mandibular Advancement Devices: NarvalTM and TALITM
Time frame: at the end of the 3-month period
The difference of effectiveness between Mandibular Advancement Devices will be assessed using the difference of delta AHI, measured by Polysomnography, between the visit 2 (M3) and the Polysomnography before Mandibular Advancement Devices installation.
9 secondary outcomes
To compare the efficacy of titration with each Mandibular Advancement Devices
Time frame: between the oral appliance delivery and the end of the titration period at 3 months
To compare the number of patients appropriately treated by Mandibular Advancement Devices between the two devices
Time frame: after 3 months of treatment with mandibular advancement device
To compare the tolerance in the 2 arms
Time frame: after 3 months of treatment
To compare the sleep quality
Time frame: after 3 months of treatment with mandibular advancement device
To compare the mandible behavior (mandibular movement (MM)) during sleep) with each Mandibular Advancement Device
Time frame: after 1 month and 3 month of treatment with each Mandibular Advancement Device
To compare the evolution of obstructive sleep apnea associated subjective daytime sleepiness with each Mandibular Advancement Device
Time frame: after 3 months of treatment with each Mandibular Advancement Device
To compare subjective snoring perception by the patient's environment
Time frame: after 3 months of treatment with each Mandibular Advancement Device
To compare patient satisfaction
Time frame: after 3 months of treatment with mandibular advancement device
To compare the effect of obstructive sleep apnea on patient's quality of life
Time frame: after 3 months of treatment with each Mandibular Advancement Device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud TAMISIER, MD, PhD principal investigator
Grenoble University Hospital, La Tronche 38700, France,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom-made adjustable mandibular advancement device in people with Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renaud TAMISIER, MD, PhD (+33(0)4 76 76 84 69, RTamisier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of efficacy of two Mandibular Advancement Devices: NarvalTM and TALITM (time frame: at the end of the 3-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.