Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 25 |
| Updated: | 6/7/2018 |
| Start Date: | August 2016 |
| End Date: | July 31, 2019 |
| Contact: | Geoffrey Rulong, MD |
| Email: | Geoffrey.Rulong@cchmc.org |
| Phone: | 513-803-3984 |
Custom 3-D Printed Noninvasive Ventilation Mask
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.
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.
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.
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.
Inclusion Criteria:
- On stable NIV settings for a minimum of 2 months.
Exclusion Criteria:
- New diagnosis
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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