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

Apnea Syndrome Clinical Trial

— SONAR  

Official title:

Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474756
• Other study ID #: 2019-A01714-53
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 2021

Study information

• Verified date: July 2020
• Source: University Hospital, Grenoble
• Contact: Renaud TAMISIER, MD, PhD
• Phone: +33(0)4 76 76 84 69
• Email: RTamisier[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed written informed consent before participation

2. Age =18 years

3. 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).

4. Naïve from any mandibular advancement device

5. Patient affiliated to a social security/health insurance system

Exclusion Criteria:

1. 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)

2. More than 20% of central apnea and hypopnea

3. Severe psychiatric or neuromuscular disorder

4. Body Mass Index (BMI) > 30 kg/m2

5. Current orthodontic treatment or planned during the study

6. Pregnant women based on clinical exam and medical questioning.

7. Subject in exclusion period of another interventional study

8. Subject under administrative or judicial control

9. Subject unable to understand, follow objectives or methods due to cognition or language problems

Related Conditions & MeSH terms

• Apnea Syndrome
• Sleep Apnea Syndromes

Intervention

Device:
• custom-made adjustable mandibular advancement 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.

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the efficacy of titration with each Mandibular Advancement Devices	Delay of titration period, number of additional titration visits required	between the oral appliance delivery and the end of the titration period at 3 months
Secondary	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	after 3 months of treatment with mandibular advancement device
Secondary	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	after 3 months of treatment
Secondary	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.	after 3 months of treatment with mandibular advancement device
Secondary	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)	after 1 month and 3 month of treatment with each Mandibular Advancement Device
Secondary	To compare the evolution of obstructive sleep apnea associated subjective daytime sleepiness with each Mandibular Advancement Device	by Epworth sleepiness score	after 3 months of treatment with each Mandibular Advancement Device
Secondary	To compare subjective snoring perception by the patient's environment	by subjective snoring (visual analogic scale-VAS)	after 3 months of treatment with each Mandibular Advancement Device
Secondary	To compare patient satisfaction	using the Questionnaire VSQ-VF	after 3 months of treatment with mandibular advancement device
Secondary	To compare the effect of obstructive sleep apnea on patient's quality of life	by Quebec Quality of life questionnaire	after 3 months of treatment with each Mandibular Advancement Device