3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea

April 14, 2020 updated by: Glenn Green

Personalized Three-Dimensionally Printed CPAP Masks for Obstructive Sleep Apnea Therapy in Children With Craniofacial Anomalies

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.

Study Overview

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 (e.g. Pierre-Robin, Treacher Collins, etc.), generally because of small, short jaws, midface hypoplasia, and/or 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 (e.g. 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 patient's photographs
  3. Generation of a topographic model of the patient's facial anatomy utilizing the 3dMDface system (specifics below) which will be export as a Stereolithography (.STL) file.

The patient's 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 usage/compliance.

Data collection will include:

  • Objective data regarding the nature of each patient's 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 mask(s).
  • 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 (e.g. 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 patient's 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 patient's 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 patient's 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 subject's CPAP machines from prior 1 month's 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 subject's CPAP machines from prior 1 month's 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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On-going need for CPAP therapy based on polysomnography
  • Inability to tolerate CPAP attributed to poor fit by a sleep clinician
  • The opinion of a sleep clinician that reasonable commercially available mask options have been exhausted
  • Caregivers must also be proficient in English to complete standard questionnaires.

Exclusion Criteria:

  • Subjects no longer needing CPAP therapy
  • Subjects able to successfully use a commercially available mask.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Arm
Intervention: Subjects will undergo assessment and a personalized CPAP mask device will be manufactured using patient-specific computer-aided design and 3D printing. The subject will use the personalized CPAP mask for 1 month of consistent use and post-intervention data will be collected for compare to historical control (see other arm)
Personalized CPAP mask manufactured for study subjects using a combination of patient-specific computer-aided design and three-dimensional printing
NO_INTERVENTION: Historical Control Arm
Pre-interventional baseline data on subject OSA, CPAP compliance, and quality of life (QoL) measures will be collected to serve as historical controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CPAP Compliance at 1 month
Time Frame: 1 month
Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Average hours usage will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value in hours per night.
1 month
Change in CPAP Leak Rate at 1 month
Time Frame: 1 month
Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Leak in liters per minute will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value in liters per minute.
1 month
Change in residual AHI on CPAP at 1 month
Time Frame: 1 month
Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Residual apnea-hypopnea index (AHI) will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value denoting AHI.
1 month
Change in time spent in large leak on CPAP at 1 month
Time Frame: 1 month
Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Percentage (%) time spent in large leak per night will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical percentage as a percentage of total time spent in large leak per night over total time using CPAP per night.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life via OSA-18 questionnaire
Time Frame: 1 month
Subject's parents or legal guardians will complete OSA-18 questionnaire (validated OSA quality of of life questionnaires) pre-intervention (baseline) and at 1-month post-intervention. These will be compared to assess effect on quality of life of the interventional device. Outcome will be measured as a numerical value as sum of all question value responses.
1 month
Safety outcomes: Comfort at baseline
Time Frame: Baseline
Subjects will be assessed clinically when first wearing the interventional device to ensure there are no issues with device fit, comfort, or undue forces on the face. Outcome will be measured as a binary numerical value with 0 denoting no issues with comfort and 1 denoting issues with comfort.
Baseline
Safety outcomes: Comfort at 1 month
Time Frame: 1 month
Subjects will be assessed clinically after using the personalized mask consistently for 1 month at home to ensure there are no issues with device fit, comfort or undue forces on the face. Subject's parents or legal guardians are instructed to contact the study team for earlier follow-up at anytime if any concerns about device fit or use occur. Outcome will be measured as a binary numerical value with 0 denoting no issues with comfort and 1 denoting issues with comfort.
1 month
Safety outcomes: Skin reaction at 1 month
Time Frame: 1 month
Subjects will be assessed clinically after using the personalized mask consistently for 1 month at home to ensure there are no issues with skin reaction or breakdown on the face. Subject's parents or legal guardians are instructed to contact the study team for earlier follow-up at anytime if any concerns about device fit or use occur. Outcome will be measured as a binary numerical value with 0 denoting no issues with skin reaction and 1 denoting issues with skin reaction.
1 month
Change in Quality of Life via PSQ questionnaire
Time Frame: 1 month
Subject's parents or legal guardians will complete PSQ questionnaire (validated OSA quality of of life questionnaires) pre-intervention (baseline) and at 1-month post-intervention. These will be compared to assess effect on quality of life of the interventional device. Outcome will be measured as a numerical value as sum of all question value responses.
1 month
Safety outcomes: durability at 1 month
Time Frame: 1 month
Subjects will be assessed clinically after using the personalized mask consistently for 1 month at home to ensure there are no issues with excessive wear or tear of the personalized mask. Subject's parents or legal guardians are instructed to contact the study team for earlier follow-up at anytime if any concerns about device fit or use occur. Outcome will be measured as a binary numerical value with 0 denoting no issues with durability and 1 denoting issues with durability.
1 month
Safety outcomes: Skin reaction at 12 months
Time Frame: 12 months
Subjects will be assessed clinically after using the personalized mask consistently for 12 months at home to ensure there are no issues with skin reaction or breakdown on the face. Subject's parents or legal guardians are instructed to contact the study team for earlier follow-up at anytime if any concerns about device fit or use occur. Outcome will be measured as a binary numerical value with 0 denoting no issues with skin reaction and 1 denoting issues with skin reaction.
12 months
Safety outcomes: Durability at 12 months
Time Frame: 12 months
Subjects will be assessed clinically after using the personalized mask consistently for 12 months at home to ensure there are no issues with excessive wear or tear of the personalized mask. Subject's parents or legal guardians are instructed to contact the study team for earlier follow-up at anytime if any concerns about device fit or use occur. Outcome will be measured as a binary numerical value with 0 denoting no issues with durability and 1 denoting issues with durability.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Glenn E Green, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (ESTIMATE)

October 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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