<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04474756</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A01714-53</org_study_id>
    <nct_id>NCT04474756</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) During Sleep</brief_title>
  <acronym>SONAR</acronym>
  <official_title>Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive&#xD;
      airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance&#xD;
      and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance&#xD;
      in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge&#xD;
      on the market without clear evidence regarding the best technical choice and the&#xD;
      cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no&#xD;
      study has tested the difference between MADs in term of efficacy, tolerance and patient&#xD;
      satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs -&#xD;
      custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a&#xD;
      3-month period, in patients with obstructive sleep apnea (OSA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive Sleep Apnea (OSA) is characterized by repetitive episodes of partial or complete&#xD;
      pharyngeal obstruction during sleep. OSA is one of the most frequent chronic diseases with&#xD;
      both social and multi-organ consequences making it an economic burden for society. OSA&#xD;
      durably impairs the quality of life of patients and their entourage and is associated with&#xD;
      co-morbidities including hypertension, arrhythmias, stroke, coronary heart disease and&#xD;
      metabolic dysfunction.&#xD;
&#xD;
      Continuous positive airway pressure (CPAP), the first line therapy for OSA, requires high&#xD;
      adherence to be effective in terms of symptom improvement and reduction of the burden of&#xD;
      co-morbidities. For one third of patients, such adherence is difficult to achieve in the long&#xD;
      term and mandibular advancement devices (MAD) have emerged as the leading alternative to&#xD;
      CPAP. So, MADs are now a reliable alternative to CPAP treatments, which position these in&#xD;
      numerous patients as a first therapy. Moreover, mild to moderate symptomatic patients who&#xD;
      refuse to be diagnosed are now referring to sleep centers in order to be treated. MAD and&#xD;
      CPAP are similarly effective on symptoms, quality of life and in attaining reductions in&#xD;
      blood pressure and cardiovascular morbidity. Although CPAP has a greater effect on Apnea +&#xD;
      hypopnea index (AHI) reduction, adherence is better with MAD explaining the comparable mean&#xD;
      disease alleviation achieved by the two treatment modalities.&#xD;
&#xD;
      Despite good tolerance and efficacy, there are still barriers limiting the widespread use of&#xD;
      MAD and its acceptance in OSA routine clinical practice. Various different MAD designs&#xD;
      currently exist and constantly emerge on the market without clear evidence regarding the best&#xD;
      technical choice and the cost-effectiveness compromise. Titratable two-piece custom-made MADs&#xD;
      are the gold standard in clinical guidelines and several brands are now on the market.&#xD;
      Although these MAD has been tested in term of efficacy, no study has tested the difference&#xD;
      between MADs in term of efficacy, tolerance and patient satisfaction. Such a paradigm merits&#xD;
      being tested in a randomized controlled trial. The SONAR study is a multicenter,&#xD;
      parallel-group randomized controlled trial to determine if the titratable MAD NARVAL TM is&#xD;
      superior to the titratable MAD TALITM in OSA patients eligible for MAD. The primary outcome&#xD;
      will be the treatment response at 3 months assessed by the difference of delta AHI at&#xD;
      baseline and follow-up measured by polysomnography and secondary outcomes focus at global&#xD;
      efficacy, tolerance and patient satisfaction.&#xD;
&#xD;
      To our knowledge it will be the first study comparing two titrable MADs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open, multicenter study in 90 obstructive sleep apnea (OSA) patients</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of efficacy of two Mandibular Advancement Devices: NarvalTM and TALITM</measure>
    <time_frame>at the end of the 3-month period</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the efficacy of titration with each Mandibular Advancement Devices</measure>
    <time_frame>between the oral appliance delivery and the end of the titration period at 3 months</time_frame>
    <description>Delay of titration period, number of additional titration visits required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the number of patients appropriately treated by Mandibular Advancement Devices between the two devices</measure>
    <time_frame>after 3 months of treatment with mandibular advancement device</time_frame>
    <description>Rate of complete response (AHI&lt;10) or partial response (AHI&lt;15) of treatment:&#xD;
The percentage of patients with AHI &lt;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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the tolerance in the 2 arms</measure>
    <time_frame>after 3 months of treatment</time_frame>
    <description>Rate of side effects, jaw discomfort (visual analogic scale) scale), mean number of hours by night wearing the mandibular device (patient diary), therapy withdrawals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the sleep quality</measure>
    <time_frame>after 3 months of treatment with mandibular advancement device</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the mandible behavior (mandibular movement (MM)) during sleep) with each Mandibular Advancement Device</measure>
    <time_frame>after 1 month and 3 month of treatment with each Mandibular Advancement Device</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the evolution of obstructive sleep apnea associated subjective daytime sleepiness with each Mandibular Advancement Device</measure>
    <time_frame>after 3 months of treatment with each Mandibular Advancement Device</time_frame>
    <description>by Epworth sleepiness score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare subjective snoring perception by the patient's environment</measure>
    <time_frame>after 3 months of treatment with each Mandibular Advancement Device</time_frame>
    <description>by subjective snoring (visual analogic scale-VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare patient satisfaction</measure>
    <time_frame>after 3 months of treatment with mandibular advancement device</time_frame>
    <description>using the Questionnaire VSQ-VF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the effect of obstructive sleep apnea on patient's quality of life</measure>
    <time_frame>after 3 months of treatment with each Mandibular Advancement Device</time_frame>
    <description>by Quebec Quality of life questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Mandibular Advancement Devices Narval™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mandibular Advancement Devices TALI ™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control device TALI ™ is a mandibular advancement orthesis, customized and manufactured by the &quot;laboratoire TALI&quot;, 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>custom-made adjustable mandibular advancement device</intervention_name>
    <description>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.</description>
    <arm_group_label>Mandibular Advancement Devices Narval™</arm_group_label>
    <arm_group_label>Mandibular Advancement Devices TALI ™</arm_group_label>
    <other_name>mandibular advancement orthosis (MAD)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written informed consent before participation&#xD;
&#xD;
          2. Age ≥18 years&#xD;
&#xD;
          3. Moderate to severe OSA defined by:&#xD;
&#xD;
               -  AHI ≥30 or,&#xD;
&#xD;
               -  15≤ AHI &lt;30, but associated with excessive daytime sleepiness or,&#xD;
&#xD;
               -  15≤ AHI &lt;30, with at least two of the following criteria not explained by other&#xD;
                  factors: severe and daily snoring, choking or suffocating sensation during sleep,&#xD;
                  non-restorative sleep, daytime fatigue, difficulty concentrating, nocturia (more&#xD;
                  than one urination per night).&#xD;
&#xD;
          4. Naïve from any mandibular advancement device&#xD;
&#xD;
          5. Patient affiliated to a social security/health insurance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. One or more of the following contra-indications:&#xD;
&#xD;
               -  dental problems (tooth failure, poor distribution or insufficient dental&#xD;
                  retention)&#xD;
&#xD;
               -  periodontal problems: active periodontitis not stabilized. Presence of&#xD;
                  periodontal pockets, advanced bone loss, significant tooth mobility, insufficient&#xD;
                  dental plaque control.&#xD;
&#xD;
               -  temporomandibular joint disorder (TJD)&#xD;
&#xD;
               -  maximum mandibular propulsion distance limited (&lt; 6 mm)&#xD;
&#xD;
          2. More than 20% of central apnea and hypopnea&#xD;
&#xD;
          3. Severe psychiatric or neuromuscular disorder&#xD;
&#xD;
          4. Body Mass Index (BMI) &gt; 30 kg/m2&#xD;
&#xD;
          5. Current orthodontic treatment or planned during the study&#xD;
&#xD;
          6. Pregnant women based on clinical exam and medical questioning.&#xD;
&#xD;
          7. Subject in exclusion period of another interventional study&#xD;
&#xD;
          8. Subject under administrative or judicial control&#xD;
&#xD;
          9. Subject unable to understand, follow objectives or methods due to cognition or&#xD;
             language problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renaud TAMISIER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grenoble University Hospital, La Tronche 38700, France,</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renaud TAMISIER, MD, PhD</last_name>
    <phone>+33(0)4 76 76 84 69</phone>
    <email>RTamisier@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie PEETERS</last_name>
    <phone>+33(0)4 76 76 92 65</phone>
    <email>MPeeters@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <state>Isère</state>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renaud TAMISIER, MD, PhD</last_name>
      <phone>+33(0)4 76 76 84 69</phone>
      <email>RTamisier@chu-grenoble.fr</email>
    </contact>
    <contact_backup>
      <last_name>Marie PEETERS</last_name>
      <phone>+33(0)4 76 76 92 65</phone>
      <email>MPeeters@chu-grenoble.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 26, 2019</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>mandibular advancement devices</keyword>
  <keyword>Mandibular movement</keyword>
  <keyword>Polysomnography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474756
org study id: 2019-A01714-53
nct id: NCT04474756
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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).
primary purpose: Treatment
masking: None (Open Label)
masking description: open, multicenter study in 90 obstructive sleep apnea (OSA) patients
measure: Comparison of efficacy of two Mandibular Advancement Devices: NarvalTM and TALITM
time frame: at the end of the 3-month period
description: 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.
measure: 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
description: Delay of titration period, number of additional titration visits required
measure: 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
description: 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
measure: To compare the tolerance in the 2 arms
time frame: after 3 months of treatment
description: Rate of side effects, jaw discomfort (visual analogic scale) scale), mean number of hours by night wearing the mandibular device (patient diary), therapy withdrawals
measure: To compare the sleep quality
time frame: after 3 months of treatment with mandibular advancement device
description: 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.
measure: 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
description: 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)
measure: 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
description: by Epworth sleepiness score
measure: To compare subjective snoring perception by the patient's environment
time frame: after 3 months of treatment with each Mandibular Advancement Device
description: by subjective snoring (visual analogic scale-VAS)
measure: To compare patient satisfaction
time frame: after 3 months of treatment with mandibular advancement device
description: using the Questionnaire VSQ-VF
measure: 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
description: by Quebec Quality of life questionnaire
arm group label: Mandibular Advancement Devices Narval™
arm group type: Experimental
description: 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.
arm group label: Mandibular Advancement Devices TALI ™
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: custom-made adjustable mandibular advancement device
description: 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.
arm group label: Mandibular Advancement Devices Narval™
arm group label: Mandibular Advancement Devices TALI ™
other name: mandibular advancement orthosis (MAD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renaud TAMISIER, MD, PhD
role: Principal Investigator
affiliation: Grenoble University Hospital, La Tronche 38700, France,
last name: Renaud TAMISIER, MD, PhD
phone: +33(0)4 76 76 84 69
email: RTamisier@chu-grenoble.fr
last name: Marie PEETERS
phone: +33(0)4 76 76 92 65
email: MPeeters@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
sharing ipd: No