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

Sleep Apnea Clinical Trial

Official title:

Custom 3-D Printed Noninvasive Ventilation Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896751
• Other study ID #: CIN001-3D Printer NIV Mask
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 7, 2022

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• New diagnosis

Related Conditions & MeSH terms

• Apnea
• Pediatric Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• 3D printed NIV mask
use of 3D printed mask

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence Rate	Change to usage of PAP (Positive Airway Pressure) treatment as measured through data downloaded from PAP machine.	6 months