Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
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|ClinicalTrials.gov Identifier: NCT02896751|
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Pediatric Sleep Apnea||Device: 3D printed NIV mask||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Custom 3-D Printed Noninvasive Ventilation Mask|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: 3D Printed NIV Mask
3D imaging and use of a custom mask from 3D printer
Device: 3D printed NIV mask
use of 3D printed mask
- Adherence Rate [ Time Frame: 6 months ]Change to usage of PAP (Positive Airway Pressure) treatment as measured through data downloaded from PAP machine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896751
|Contact: Geoffrey Rulong, MD||513-803-3984||Geoffrey.Rulong@cchmc.org|
|Contact: Narong Simakajornboon, MD||513-636-3762||Narong.Simakajornboon@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Geofrey Rulong, MD|
|Sub-Investigator: Geofrey Rulong, MD|
|Principal Investigator:||Narong Simakajornboon, MD||Cincinnati Children's Hopital Medical Center|