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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896751
Other study ID # CIN001-3D Printer NIV Mask
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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