Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612008
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Superimposition of Intra-oral Scans in MAD Therapy for OSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Superimposition of Intra-oral Scans in Mandibular Advancement Device MAD Therapy for Obstructive Sleep Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMT-OSA
Brief Summary:
Obstructive Sleep Apnea OSA affects quality of life and health Mandibular Advancement Devices MAD can help with OSA but may cause dental and jaw changes This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients
Goals
1 To track dental and jaw changes in OSA patients using 3D scans
2 To assess the impact of MAD on quality of life and cognitive function
Study Details
The aim of the study is to follow OSA patients at multiple centers over several years comparing two MAD adjustment methods Participants will undergo routine fitting and imaging
Outcome
The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes
Goals
1 To track dental and jaw changes in OSA patients using 3D scans
2 To assess the impact of MAD on quality of life and cognitive function
Study Details
The aim of the study is to follow OSA patients at multiple centers over several years comparing two MAD adjustment methods Participants will undergo routine fitting and imaging
Outcome
The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes
Detailed Description:
Rationale Obstructive Sleep Apnea OSA significantly reduces quality of life and increases the risk of severe health issue While Mandibular Advancement Devices MAD are effective in managing OSA symptoms they often introduce undesirable dental and skeletal changes which can have a negative impact on patient satisfaction Recognizing this issue this study hypothesizes that using an innovative 3D superimposition technique to track these changes will allow to compare two different titration protocols more precisely and determine the optimal approach for various patient groups By identifying the most effective titration protocol the aim is to enhance treatment adherence and treatment success addressing a critical gap in existing literature and significantly improving patient outcomes in OSA treatment
Objective
1 Investigate dental and skeletal changes in OSA patients undergoing MAD treatment using an innovative 3D superimposition technique
2 Assess the impact of MAD treatment on quality of life QoL and cognitive function
Study design A prospective multicentre observational cohort study will be conducted involving four screening points at the studys onset and during the first second and third annual follow-up assessments This investigation will involve two patient cohorts undergoing different titration approaches orthodontic titration and another commonly used titration protocol
Study population The study will include adults with mild to moderate OSA who will undergo MAD treatment
Intervention Participants will be fitted with a MAD as part of their routine clinical care The intervention involves the collection of baseline intra-oral scans IOS lateral cephalograms LCR orthopantomograms OPT and a collection of orthodontic parameters These assessments will be repeated at each follow-up appointment
Main study parametersendpoints
1 Dental and skeletal changes tracked over time using intra-oral scans IOS lateral cephalograms LCR orthopantomograms OPT and complete orthodontic evaluations
2 Changes in quality of life QoL and cognitive function assessed through validated questionnaires
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients will experience the routine procedure of MAD fitting and imaging assessments The studys positive outcomes encompass advancing the knowledge of the enduring impacts of MAD treatment on oral health Participants will not incur any additional risks by engaging in this research as it solely involves additional routine diagnostic procedures The study is group-related focusing on OSA patients undergoing MAD therapy
Objective
1 Investigate dental and skeletal changes in OSA patients undergoing MAD treatment using an innovative 3D superimposition technique
2 Assess the impact of MAD treatment on quality of life QoL and cognitive function
Study design A prospective multicentre observational cohort study will be conducted involving four screening points at the studys onset and during the first second and third annual follow-up assessments This investigation will involve two patient cohorts undergoing different titration approaches orthodontic titration and another commonly used titration protocol
Study population The study will include adults with mild to moderate OSA who will undergo MAD treatment
Intervention Participants will be fitted with a MAD as part of their routine clinical care The intervention involves the collection of baseline intra-oral scans IOS lateral cephalograms LCR orthopantomograms OPT and a collection of orthodontic parameters These assessments will be repeated at each follow-up appointment
Main study parametersendpoints
1 Dental and skeletal changes tracked over time using intra-oral scans IOS lateral cephalograms LCR orthopantomograms OPT and complete orthodontic evaluations
2 Changes in quality of life QoL and cognitive function assessed through validated questionnaires
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients will experience the routine procedure of MAD fitting and imaging assessments The studys positive outcomes encompass advancing the knowledge of the enduring impacts of MAD treatment on oral health Participants will not incur any additional risks by engaging in this research as it solely involves additional routine diagnostic procedures The study is group-related focusing on OSA patients undergoing MAD therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None