Clinical trials: Mandibular Advancement
Obstructive Sleep Apnea
RPMO2 Oximeter Accuracy During Sleep 1 Trial
The goal of this observational study is to validate the accuracy of the RPMO2 OSA Device's oxygen desaturation index in individuals with obstructive sleep apnea versus the gold standard, in-lab polysomnography.
- Trial name
- ROADS-1 (NCT07397780)
- Testing
- RPMO2 OSA Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ProSomnus Sleep Technologies
Sleep Apnea, Snoring
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study. The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by…
- Trial name
- NCT04250584
- Testing
- iSlpr™, SomnoDent® Classic
- Volunteers
- 66 people
- Sponsor
- BioAnalytics Holdings Pty Ltd
Obstructive Sleep Apnea
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use.
- Trial name
- IRIS (NCT02348970)
- Testing
- ONIRIS®, TALI
- Where
- 10 sites in France
- Volunteers
- 211 people
- Sponsor
- ONIRIS
Syndrome of Obstructive Sleep Apnea and Hypopneas
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
- Trial name
- NCT02878629
- Testing
- Mandibular Advancement Devices
- Where
- France
- Volunteers
- 254 people
- Sponsor
- ONIRIS
Obstructive Sleep Apnea
Severe Label Expansion for EVO Products Trial
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus…
- Trial name
- SLEEP (NCT07090395)
- Testing
- EVO Sleep and Snore Device
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- ProSomnus Sleep Technologies
Sleep Apnea, Obstructive
Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea
Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients.
- Trial name
- PANTHERA (NCT05461417)
- Testing
- D-SAD
- Where
- France
- Volunteers
- 337 people
- Sponsor
- Panthera Dental Inc.
Obstructive Sleep Apnea (OSA)
INFORMing Patients With Oximetry Data to Improve MAD Engagement
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.
- Trial name
- INFORM (NCT07564310)
- Testing
- Narval MRD device, MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
- Volunteers
- 120 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur.
- Trial name
- PATT-OSA (NCT03924817)
- Where
- 4 sites in Germany
- Volunteers
- 500 people
- Sponsor
- ResMed
Class II Malocclusion, Mandibular Advancement
Invisalign® System with Mandibular Advancement
The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement…
- Conditions
- Class II Malocclusion, Mandibular Advancement, Mandibular Retrognathism, Excessive Overjet
- Trial name
- NCT06651944
- Testing
- Invisalign® System with mandibular advancement featuring occlusal blocks
- Where
- 3 sites in Canada
- Volunteers
- 36 people
- Sponsor
- Align Technology, Inc.
OSA
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data.
- Trial name
- REMAP (NCT05435794)
- Testing
- CPAP, MAD
- Where
- 9 sites in France
- Volunteers
- 400 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Sleep Apnea
Severe OSA Study (SOS)
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
- Trial name
- NCT05445869
- Testing
- ProSomnus® EVO Sleep and Snore Device
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- ProSomnus Sleep Technologies