Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05461417
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2022-06-29
Brief Title:
Long-term Efficacy Tolerance and Compliance of Panthera D-SAD Mandibular Advancement Orthosis in Sleep Apnea
Sponsor:
Panthera Dental Inc
Organization:
Panthera Dental Inc
Study Overview
Official Title:
Non-comparative Prospective Study Evaluating the Long-term Efficacy Tolerance and Compliance of the Panthera D-SAD Mandibular Advancement Orthosis in the Management of Obstructive Sleep Apnea Hypopnea Syndrome PANTHERA Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
PANTHERA
Brief Summary:
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 The Panthera D-SAD is a computer aided design CADcomputer aided manufacturing CAM patient-matched 3D printed biocompatible nylon OAT This five-year observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD orthosis on reducing the apnea hypopnea index AHI and obstructive sleep apnea-hypopnea syndrome OSAHS symptoms Adherence tolerance and side effects will be evaluated
An estimated ten sites composed of a professional dyad a specialist in sleep disorders and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria no prior use of OAT and struggles or refuses continuous positive airway CPAP treatment The professional collaborative nature of the study reflects real-world clinical practice
Participants will be followed over the course of five years at the following time points Visits include the following Specialist in sleep disorders 1 Inclusion 2 3 months 3 2 years 4 5 years Specialist in manducatory apparatus dentist 1 Inclusion orthosis set-up and titration 2 6 months 3 2 and 4 5 years The efficacy of the Panthera D-SAD MAO will be assessed by the treatment success rate at five years defined as a reduction 50 in the initial AHI when monitored by nocturnal breathing polygraphy NP or polysomnography PSG Secondary endpoints will also be obtained at the aforementioned time points for reporting The results of this study will fulfill regulatory requirements for reimbursement in France
An estimated ten sites composed of a professional dyad a specialist in sleep disorders and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria no prior use of OAT and struggles or refuses continuous positive airway CPAP treatment The professional collaborative nature of the study reflects real-world clinical practice
Participants will be followed over the course of five years at the following time points Visits include the following Specialist in sleep disorders 1 Inclusion 2 3 months 3 2 years 4 5 years Specialist in manducatory apparatus dentist 1 Inclusion orthosis set-up and titration 2 6 months 3 2 and 4 5 years The efficacy of the Panthera D-SAD MAO will be assessed by the treatment success rate at five years defined as a reduction 50 in the initial AHI when monitored by nocturnal breathing polygraphy NP or polysomnography PSG Secondary endpoints will also be obtained at the aforementioned time points for reporting The results of this study will fulfill regulatory requirements for reimbursement in France
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None