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Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment

Primary Purpose

Sleep Apnea, Pediatric Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D printed NIV mask
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring CPAP, Noninvasive Ventilation Mask

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • On stable NIV settings for a minimum of 2 months.

Exclusion Criteria:

  • New diagnosis

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D Printed NIV Mask

Arm Description

3D imaging and use of a custom mask from 3D printer

Outcomes

Primary Outcome Measures

Adherence Rate
Change to usage of PAP (Positive Airway Pressure) treatment as measured through data downloaded from PAP machine.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2016
Last Updated
August 23, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02896751
Brief Title
Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
Official Title
Custom 3-D Printed Noninvasive Ventilation Mask
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
March 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a small pilot study to look at the feasibility of creating a customized sleep mask for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep apnea. The participant will have three dimensional (3D) pictures of the face taken by special cameras. The pictures will be sent to a 3D printer and a mask will be created based on the participant's face contours. The participant will use the mask for about 6 months. The study will measure the amount it is used during sleep and if there is an increase in reported comfort.
Detailed Description
The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is successful at treating obstructive sleep apnea and hypoventilation, individuals have poor compliance with therapy. The reasons for poor compliance are numerous, but one significant and continually reported reason is poor mask fit. A poor mask fit is not only uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around the mask. Pediatric patients tend to be especially difficult to fit with conventional masks because of their smaller facial features and the lack of masks developed for pediatric use. In this study, patients will be fitted with a custom made NIV mask following facial imaging with a 3D camera (Artec 3D Scanner). The facial image will be used to construct an NIV mask model using computer design software that will then be created by using a 3D printer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Pediatric Sleep Apnea
Keywords
CPAP, Noninvasive Ventilation Mask

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D Printed NIV Mask
Arm Type
Experimental
Arm Description
3D imaging and use of a custom mask from 3D printer
Intervention Type
Device
Intervention Name(s)
3D printed NIV mask
Intervention Description
use of 3D printed mask
Primary Outcome Measure Information:
Title
Adherence Rate
Description
Change to usage of PAP (Positive Airway Pressure) treatment as measured through data downloaded from PAP machine.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: On stable NIV settings for a minimum of 2 months. Exclusion Criteria: New diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narong Simakajornboon, MD
Organizational Affiliation
Cincinnati Children's Hopital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with treating sleep physicians to improve care

Learn more about this trial

Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment

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