Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) During Sleep

NCT04474756 | Unknown

• 1 other identifier: 2019-A01714-53
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Apnea Syndrome

Keywords

Obstructive Sleep Apnea; mandibular advancement devices; Mandibular movement; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of the 3-month period

Secondary Outcomes (9)

• To compare the efficacy of titration with each Mandibular Advancement Devices

  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

  after 3 months of treatment with mandibular advancement device

• To compare the tolerance in the 2 arms

  after 3 months of treatment

• To compare the sleep quality

  after 3 months of treatment with mandibular advancement device

• To compare the mandible behavior (mandibular movement (MM)) during sleep) with each Mandibular Advancement Device

  after 1 month and 3 month of treatment with each Mandibular Advancement Device

Study Arms (2)

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.

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.

Device: custom-made adjustable mandibular advancement device

Interventions

custom-made adjustable mandibular advancement device DEVICE

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.

Also known as: mandibular advancement orthosis (MAD)

Mandibular Advancement Devices Narval™; Mandibular Advancement Devices TALI ™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent before participation
• Age ≥18 years
• Moderate to severe OSA defined by:
• AHI ≥30 or,
• ≤ AHI \<30, but associated with excessive daytime sleepiness or,
• ≤ 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

You may not qualify if:

• 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
• 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 under administrative or judicial control
• Subject unable to understand, follow objectives or methods due to cognition or language problems

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, Isère, 38700, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Renaud TAMISIER, MD, PhD

  Grenoble University Hospital, La Tronche 38700, France,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud TAMISIER, MD, PhD

CONTACT

+33(0)4 76 76 84 69; RTamisier@chu-grenoble.fr

Marie PEETERS

CONTACT

+33(0)4 76 76 92 65; MPeeters@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open, multicenter study in 90 obstructive sleep apnea (OSA) patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: July 17, 2020
• Study Start: June 15, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)