Apnea Syndrome Clinical Trial
— SONAROfficial 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).
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 |
Country | Name | City | State |
---|---|---|---|
France | Grenoble University Hospital | Grenoble | Isère |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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 |
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