Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02261857
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2014-09-29
Brief Title:
3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea
Sponsor:
Glenn Green
Organization:
University of Michigan
Study Overview
Official Title:
Personalized Three-Dimensionally Printed CPAP Masks for Obstructive Sleep Apnea Therapy in Children With Craniofacial Anomalies
Status:
COMPLETED
Status Verified Date:
2020-04
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:
The purpose of this study is to determine whether patient-specific computer-aided design CAD and three-dimensional 3D printing can be utilized to produce personalized effective continuous positive airway pressure CPAP masks for children with severe obstructive sleep apnea OSA and craniofacial anomalies who encounter significant difficulty using CPAP because of poorly fitting masks despite exhausting available commercial mask options
Detailed Description:
Obstructive sleep apnea OSA is a common problem in the general pediatric population generally cited as between 1-5 with morbidity ranging from daytime behavioral problems and inattention to cardiopulmonary effects including hypertension and ventricular hypertrophy OSA is dramatically more prevalent among children with certain craniofacial anomalies and syndromes eg Pierre-Robin Treacher Collins etc generally because of small short jaws midface hypoplasia andor disproportionally large tongues While tonsillectomy and adenoidectomy is considered first line therapy for OSA in the general pediatric population children with OSA due to craniofacial anomalies frequently require more aggressive intervention to improve their breathing at night which often includes continuous positive airway pressure ventilation CPAP Most children who require CPAP therapy are able to find a mask that will adequately seal while providing acceptable comfort however a small percentage of children encounter significant difficulty finding a functional CPAP interface most often because of dysmorphic facial features This can prove a significant barrier to effective CPAP therapy and lead to frustration on the part of patients caregivers and providers as well as the associated morbidity of untreated severe OSA The purpose of this feasibility study is to investigate the use of patient-specific computational design and three-dimensional 3D printing to produce personalized CPAP masks for children intolerant of standard CPAP masks due to poor fit secondary to craniofacial anomalies who encounter significant difficulty using CPAP because of poorly fitting masks despite exhausting available commercial mask options
Study Design
This will be a prospective case study examining the feasibility of using patient-specific CAD and 3D printing technology to produce personalized CPAP masks for children intolerant of commercially available masks due to poor fit Patients will be recruited from the pediatric otolaryngology pediatric oral maxillofacial surgery and pediatric sleep clinics at the University of Michigan Medical Center with a target cohort of five
Only patients of study team members will be included in the study and no recruitment will take place outside the clinics of participating study team members We anticipate the study period to last 3 years though it may terminate sooner if recruitment targets are reached expeditiously
After recruitment and consent of a potential study subject each subject will undergo an initial mask-design evaluation with members of the research team At this initial visit the following will be performed
1 A head neck physical exam which a focus on characteristics important for treatment of OSA eg jaw size and position tongue size and position characteristics of palate presence or absence of cleft external nasal deformity external or internal nasal valvular collapse
2 Review of patients photographs
3 Generation of a topographic model of the patients facial anatomy utilizing the 3dMDface system specifics below which will be export as a Stereolithography STL file
The patients facial STL file will then be imported into a computer-aided design CAD modeling program MimicsTM or MagicsTM Materialise Belgium Contact points along the topographic model are drawn out and utilized for modeling of the custom mask The custom mask model is then exported in STL format for import into the 3D printer for fabrication using a fused-deposition modeling FDM method Object Pro Stratasys Israel
Once the mask has been fabricated patients will undergo a mask-fit evaluation If a mask appears to fit well the patient will use it at home with home CPAP for one month of consistent use They will then return for debriefing and re-evaluation with subsequent iterations of mask design as needed If the mask functions for the patient better than any other alternatives the patient will be allowed to continue to use the mask for up to one year with ongoing surveillance by the research team assessing for mask durability and ongoing usagecompliance
Data collection will include
Objective data regarding the nature of each patients obstructive sleep apnea and CPAP pressure requirements sleep-disordered breathing from the most recent available polysomnograms sleep study abbreviated PSG
Information regarding all prior CPAP masks attempted
One month compliance data downloads from CPAP machines - with both the prior best alternative if usable and with the customized mask including percentage of days used average hours usage residual apnea-hypopnea index AHI and time spent in large leak per night
Standardized interview with patients and their parents regarding other masks used and experience with the customized masks
Descriptive anatomic information regarding facial anomalies contributing to poor mask fit obtained from physical exam photographs and imaging studies
Validated quality of life measures taken before and at completion of trial period with customized CPAP mask including the Pediatric Sleep Questionnaire PSQ and the OSA-18 to assess the impact of successful CPAP use for our patients
Analysis will involve basic descriptive statistics to describe both the objective outcomes eg compliance data from CPAP machines and quality of life measures PSQ and OSA-18 surveys as well as information on individual experiences collected during interviews
Additional Data on 3D Photography System
Patient facial modeling information will be obtained utilizing a 3dMDface system 3dMD Atlanta GA The 3dMD system is a three-dimensional photography system which generates a three-dimensional model of the patients face utilizing multiple convergent cameras see Figure 1 below The three-dimensional model is generated utilizing hybrid stereophotogrammetry with software algorithms using both projected random patterns and texture of the skin pores freckles etc to stereo-triangulate and generate a 3D surface image The 3D model of the patients face is created within the 3dMDvultus software system which can then export the model in STL format No patient identifying information is stored within the STL file
All 3D photography sessions with study subjects will be performed or supervised by one of the members of the study team There will be no cost associated with using the 3dMDface system Utilizing 3D photography allows us to obtain the most time-accurate topographic information of the patients face while avoiding the cost and risk associated with conventional CT or MRI imaging
Data Included in Registry
Pre- and post- intervention OSA-18 and PSQ questionnaire aggregates Data to be recorded includes sum score and mean score for each questionnaire
Pre-intervention AHI and oxygen saturation SpO2 nadir based on most recent sleep PSG
Pre-intervention CPAP requirements based on most recent CPAP titration PSG
Pre-intervention compliance data downloads from subjects CPAP machines from prior 1 months use Data to be recorded includes percentage of days used average hours usage residual apnea-hypopnea index AHI size of leak in liters per minute and time spent in large leak per night
Post-intervention compliance data downloads from subjects CPAP machines from prior 1 months use Data to be recorded includes percentage of days used average hours usage residual apnea-hypopnea index AHI size of leak in liters per minute and time spent in large leak per night
Data Registry QA
Physical and electronic PDF versions of each data registry primary source questionnaires polysomnograms and CPAP compliance reports will be kept for the 5 years past the duration of the study Data uploaded to the patient registry will be verified with the institutional IRB
Study Design
This will be a prospective case study examining the feasibility of using patient-specific CAD and 3D printing technology to produce personalized CPAP masks for children intolerant of commercially available masks due to poor fit Patients will be recruited from the pediatric otolaryngology pediatric oral maxillofacial surgery and pediatric sleep clinics at the University of Michigan Medical Center with a target cohort of five
Only patients of study team members will be included in the study and no recruitment will take place outside the clinics of participating study team members We anticipate the study period to last 3 years though it may terminate sooner if recruitment targets are reached expeditiously
After recruitment and consent of a potential study subject each subject will undergo an initial mask-design evaluation with members of the research team At this initial visit the following will be performed
1 A head neck physical exam which a focus on characteristics important for treatment of OSA eg jaw size and position tongue size and position characteristics of palate presence or absence of cleft external nasal deformity external or internal nasal valvular collapse
2 Review of patients photographs
3 Generation of a topographic model of the patients facial anatomy utilizing the 3dMDface system specifics below which will be export as a Stereolithography STL file
The patients facial STL file will then be imported into a computer-aided design CAD modeling program MimicsTM or MagicsTM Materialise Belgium Contact points along the topographic model are drawn out and utilized for modeling of the custom mask The custom mask model is then exported in STL format for import into the 3D printer for fabrication using a fused-deposition modeling FDM method Object Pro Stratasys Israel
Once the mask has been fabricated patients will undergo a mask-fit evaluation If a mask appears to fit well the patient will use it at home with home CPAP for one month of consistent use They will then return for debriefing and re-evaluation with subsequent iterations of mask design as needed If the mask functions for the patient better than any other alternatives the patient will be allowed to continue to use the mask for up to one year with ongoing surveillance by the research team assessing for mask durability and ongoing usagecompliance
Data collection will include
Objective data regarding the nature of each patients obstructive sleep apnea and CPAP pressure requirements sleep-disordered breathing from the most recent available polysomnograms sleep study abbreviated PSG
Information regarding all prior CPAP masks attempted
One month compliance data downloads from CPAP machines - with both the prior best alternative if usable and with the customized mask including percentage of days used average hours usage residual apnea-hypopnea index AHI and time spent in large leak per night
Standardized interview with patients and their parents regarding other masks used and experience with the customized masks
Descriptive anatomic information regarding facial anomalies contributing to poor mask fit obtained from physical exam photographs and imaging studies
Validated quality of life measures taken before and at completion of trial period with customized CPAP mask including the Pediatric Sleep Questionnaire PSQ and the OSA-18 to assess the impact of successful CPAP use for our patients
Analysis will involve basic descriptive statistics to describe both the objective outcomes eg compliance data from CPAP machines and quality of life measures PSQ and OSA-18 surveys as well as information on individual experiences collected during interviews
Additional Data on 3D Photography System
Patient facial modeling information will be obtained utilizing a 3dMDface system 3dMD Atlanta GA The 3dMD system is a three-dimensional photography system which generates a three-dimensional model of the patients face utilizing multiple convergent cameras see Figure 1 below The three-dimensional model is generated utilizing hybrid stereophotogrammetry with software algorithms using both projected random patterns and texture of the skin pores freckles etc to stereo-triangulate and generate a 3D surface image The 3D model of the patients face is created within the 3dMDvultus software system which can then export the model in STL format No patient identifying information is stored within the STL file
All 3D photography sessions with study subjects will be performed or supervised by one of the members of the study team There will be no cost associated with using the 3dMDface system Utilizing 3D photography allows us to obtain the most time-accurate topographic information of the patients face while avoiding the cost and risk associated with conventional CT or MRI imaging
Data Included in Registry
Pre- and post- intervention OSA-18 and PSQ questionnaire aggregates Data to be recorded includes sum score and mean score for each questionnaire
Pre-intervention AHI and oxygen saturation SpO2 nadir based on most recent sleep PSG
Pre-intervention CPAP requirements based on most recent CPAP titration PSG
Pre-intervention compliance data downloads from subjects CPAP machines from prior 1 months use Data to be recorded includes percentage of days used average hours usage residual apnea-hypopnea index AHI size of leak in liters per minute and time spent in large leak per night
Post-intervention compliance data downloads from subjects CPAP machines from prior 1 months use Data to be recorded includes percentage of days used average hours usage residual apnea-hypopnea index AHI size of leak in liters per minute and time spent in large leak per night
Data Registry QA
Physical and electronic PDF versions of each data registry primary source questionnaires polysomnograms and CPAP compliance reports will be kept for the 5 years past the duration of the study Data uploaded to the patient registry will be verified with the institutional IRB
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