Status:
UNKNOWN
Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) During Sleep
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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, t...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04474756
Start Date
June 15 2020
End Date
September 1 2021
Last Update
July 17 2020
Active Locations (1)
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1
Grenoble University Hospital
Grenoble, Isère, France, 38700