Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03217383
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2017-07-12
Brief Title:
Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy
Sponsor:
Zephyr Sleep Technologies
Organization:
Zephyr Sleep Technologies
Study Overview
Official Title:
Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea OSA is a common disease that is largely un-diagnosed and untreated Standard treatment for obstructive sleep apnea nasal continuous positive airway pressure CPAP entails use of a nose mask to deliver positive pressure which dilates the pharynx and eliminates obstruction This therapy is highly efficacious and benign but is associated with low adherence particularly in non-sleepy apneics with disease of mild and moderate severity The principal alternative to CPAP therapy is oral appliance OA therapy in which a custom made mandibular advancement splint MAS is used to protrude the mandible during sleep thereby opening the pharyngeal airway OA therapy while preferred and well accepted by most participants is not uniformly efficacious Additionally uncertainty regarding the patients response to OAT and the effective target mandibular position can lead to a significant time span between diagnosis and initiation of effective treatment Furthermore knowledge of the effective target mandibular position supports the use of new OA design and manufacturing processes that can further reduce the time and cost in delivering the therapy
Zephyr Sleep Technologies the Sponsor has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion Recently Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home Using a feedback controlled mandibular positioner FCMP the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible The FCMP device was tested in a blinded bi-phase clinical study in which participants with mild-to-severe sleep apnea n202 underwent two full-night studies in the home Data from phase 1 were used to develop a predictive method and data from phase 2 were used to prospectively test the accuracy of the predictive method An efficacious mandibular position was also predicted and each participant was treated with a custom oral appliance set to that position Data from both phases were used to evaluate the feasibility of use of the device in the home
A random forest machine learning system was used to develop and test the predictive method The overall oral appliance success rate was 76 for phase 1 and 71 for phase 2 The overall predictive accuracy was 88 Values for sensitivity and specificity were 85 and 93 respectively Positive and negative predictive values were 97 and 72 respectively The effective target protrusive position was identified in 86 of cases The studies were conducted independently by the participants in their homes though due to limitations in the early prototype design a clinical coordinator visited the home to set up the equipment prior to each night of study No significant problems were encountered and no significant risks were identified The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position
Based on the results of this study Zephyr developed a commercially available device which has been approved for sale in Canada Health Canada device license 97614 The device branded MATRx plus functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice
Evidence has recently appeared to indicate that the change in pharyngeal volume caused by protrusion of the mandible measured while awake correlates with the change in apnea-hypopnea index AHI achieved by OAT measured while asleep This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT Accordingly we shall carry out conebeam CTs in the research protocol both at rest position of the mandible and at 90 of maximal protrusion
The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence
Zephyr Sleep Technologies the Sponsor has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion Recently Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home Using a feedback controlled mandibular positioner FCMP the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible The FCMP device was tested in a blinded bi-phase clinical study in which participants with mild-to-severe sleep apnea n202 underwent two full-night studies in the home Data from phase 1 were used to develop a predictive method and data from phase 2 were used to prospectively test the accuracy of the predictive method An efficacious mandibular position was also predicted and each participant was treated with a custom oral appliance set to that position Data from both phases were used to evaluate the feasibility of use of the device in the home
A random forest machine learning system was used to develop and test the predictive method The overall oral appliance success rate was 76 for phase 1 and 71 for phase 2 The overall predictive accuracy was 88 Values for sensitivity and specificity were 85 and 93 respectively Positive and negative predictive values were 97 and 72 respectively The effective target protrusive position was identified in 86 of cases The studies were conducted independently by the participants in their homes though due to limitations in the early prototype design a clinical coordinator visited the home to set up the equipment prior to each night of study No significant problems were encountered and no significant risks were identified The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position
Based on the results of this study Zephyr developed a commercially available device which has been approved for sale in Canada Health Canada device license 97614 The device branded MATRx plus functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice
Evidence has recently appeared to indicate that the change in pharyngeal volume caused by protrusion of the mandible measured while awake correlates with the change in apnea-hypopnea index AHI achieved by OAT measured while asleep This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT Accordingly we shall carry out conebeam CTs in the research protocol both at rest position of the mandible and at 90 of maximal protrusion
The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence
Detailed Description:
Obstructive sleep apnea OSA is a common disease that is largely un-diagnosed and untreated Standard treatment for obstructive sleep apnea nasal continuous positive airway pressure CPAP entails use of a nose mask to deliver positive pressure which dilates the pharynx and eliminates obstruction This therapy is highly efficacious and benign but is associated with low adherence particularly in non-sleepy apneics with disease of mild and moderate severity The principal alternative to CPAP therapy is oral appliance OA therapy in which a custom made mandibular advancement splint MAS is used to protrude the mandible during sleep thereby opening the pharyngeal airway OA therapy while preferred and well accepted by most participants is not uniformly efficacious Additionally uncertainty regarding the patients response to OAT and the effective target mandibular position can lead to a significant time span between diagnosis and initiation of effective treatment Furthermore knowledge of the effective target mandibular position supports the use of new OA design and manufacturing processes that can further reduce the time and cost in delivering the therapy
Zephyr Sleep Technologies the Sponsor has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion A remotely controlled mandibular positioner RCMP is used during polysomnographic monitoring to vary the mandibular position The in-lab version of the device requiring use of a sleep technologist during a polysomnographic study was shown to accurately predict outcome with a custom oral appliance in a triple-blind prospective predictive study in sixty-seven participants with mild-to-severe sleep apnea specificity 92 PPV 94 sensitivity 86 NPV 83 In addition the predicted target mandibular protrusive position proved efficacious in 875 of cases While accurate in prospectively identifying oral appliance responders the availability and utility of the RCMP device is limited by the requirement of a polysomnographic study
Recently Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home Using a feedback controlled mandibular positioner FCMP the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible The FCMP device was tested in a blinded bi-phase clinical study in which participants with mild-to-severe sleep apnea n202 underwent two full-night studies in the home Data from phase 1 were used to develop a predictive method and data from phase 2 were used to prospectively test the accuracy of the predictive method An efficacious mandibular position was also predicted and each participant was treated with a custom oral appliance set to that position Data from both phases were used to evaluate the feasibility of use of the device in the home
A random forest machine learning system was used to develop and test the predictive method The overall oral appliance success rate was 76 for phase 1 and 71 for phase 2 The overall predictive accuracy was 88 Values for sensitivity and specificity were 85 and 93 respectively Positive and negative predictive values were 97 and 72 respectively The effective target protrusive position was identified in 86 of cases The studies were conducted independently by the participants in their homes though due to limitations in the early prototype design a clinical coordinator visited the home to set up the equipment prior to each night of study No significant problems were encountered and no significant risks were identified The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position
Based on the results of this study Zephyr developed a commercially available device which has been approved for sale in Canada Health Canada device license 97614 The device branded MATRx plus functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice
ProSomnus Sleep Technologies has developed a digitally designed and milled sleep appliance called the MicrO2 This device is designed to accurately represent the bite and targeted mandibular position minimize tongue interference maintain the targeted mandibular position throughout the night using 90-degree fin angles and use a novel titration process that can reduce error in patientdoctor titration position selection This device coupled with a digital workflow and outcome of the FCMP is postulated to provide an increase in efficiency of delivering efficacious treatment to the patient from diagnosis to final therapy
Evidence has recently appeared to indicate that the change in velo-pharyngeal volume caused by protrusion of the mandible measured while awake correlates with the change in apnea-hypopnea index AHI achieved by OAT measured while asleep This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT Accordingly we shall carry out conebeam CTs in the research protocol both at rest position of the mandible and at 90 of maximal protrusion
The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence
Zephyr Sleep Technologies the Sponsor has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion A remotely controlled mandibular positioner RCMP is used during polysomnographic monitoring to vary the mandibular position The in-lab version of the device requiring use of a sleep technologist during a polysomnographic study was shown to accurately predict outcome with a custom oral appliance in a triple-blind prospective predictive study in sixty-seven participants with mild-to-severe sleep apnea specificity 92 PPV 94 sensitivity 86 NPV 83 In addition the predicted target mandibular protrusive position proved efficacious in 875 of cases While accurate in prospectively identifying oral appliance responders the availability and utility of the RCMP device is limited by the requirement of a polysomnographic study
Recently Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home Using a feedback controlled mandibular positioner FCMP the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible The FCMP device was tested in a blinded bi-phase clinical study in which participants with mild-to-severe sleep apnea n202 underwent two full-night studies in the home Data from phase 1 were used to develop a predictive method and data from phase 2 were used to prospectively test the accuracy of the predictive method An efficacious mandibular position was also predicted and each participant was treated with a custom oral appliance set to that position Data from both phases were used to evaluate the feasibility of use of the device in the home
A random forest machine learning system was used to develop and test the predictive method The overall oral appliance success rate was 76 for phase 1 and 71 for phase 2 The overall predictive accuracy was 88 Values for sensitivity and specificity were 85 and 93 respectively Positive and negative predictive values were 97 and 72 respectively The effective target protrusive position was identified in 86 of cases The studies were conducted independently by the participants in their homes though due to limitations in the early prototype design a clinical coordinator visited the home to set up the equipment prior to each night of study No significant problems were encountered and no significant risks were identified The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position
Based on the results of this study Zephyr developed a commercially available device which has been approved for sale in Canada Health Canada device license 97614 The device branded MATRx plus functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice
ProSomnus Sleep Technologies has developed a digitally designed and milled sleep appliance called the MicrO2 This device is designed to accurately represent the bite and targeted mandibular position minimize tongue interference maintain the targeted mandibular position throughout the night using 90-degree fin angles and use a novel titration process that can reduce error in patientdoctor titration position selection This device coupled with a digital workflow and outcome of the FCMP is postulated to provide an increase in efficiency of delivering efficacious treatment to the patient from diagnosis to final therapy
Evidence has recently appeared to indicate that the change in velo-pharyngeal volume caused by protrusion of the mandible measured while awake correlates with the change in apnea-hypopnea index AHI achieved by OAT measured while asleep This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT Accordingly we shall carry out conebeam CTs in the research protocol both at rest position of the mandible and at 90 of maximal protrusion
The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None