Sleep ApneaNCT02896751
Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
A study testing 3D printed NIV mask in people with Sleep Apnea and Pediatric Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Sleep Apnea, Pediatric Sleep Apnea
- What is being tested?
- 3D printed NIV mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 7 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- On stable NIV settings for a minimum of 2 months.
Who cannot join
- New diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Pediatric Sleep Apnea
- Being tested
- 3D printed NIV mask
- Keywords
- CPAP, Noninvasive Ventilation Mask
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed NIV maskDevice
use of 3D printed mask
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed NIV Mask | Experimental | 3D imaging and use of a custom mask from 3D printer Receives: Device: 3D printed NIV mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence
Measure CPAP usage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narong Simakajornboon, MD, Principal investigator, Cincinnati Children's Hopital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896751
- Sponsor's protocol ID
- CIN001-3D Printer NIV Mask
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared with treating sleep physicians to improve care
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom 3-D Printed Noninvasive Ventilation Mask
- ClinicalTrials.gov ID
- NCT02896751
- Acronym / sponsor ID
- CIN001-3D Printer NIV Mask
- Conditions
- Sleep Apnea, Pediatric Sleep Apnea
- Keywords
- CPAP, Noninvasive Ventilation Mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Printed NIV Mask | Experimental | Device: 3D printed NIV mask3D imaging and use of a custom mask from 3D printer |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- On stable NIV settings for a minimum of 2 months.
Key exclusion criteria (1 listed)
- New diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed NIV maskuse of 3D printed mask | Device | 3D Printed NIV Mask |
Primary outcome
CPAP Adherence
Time frame: 6 months
Measure CPAP usage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Data will be shared with treating sleep physicians to improve care
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narong Simakajornboon, MD principal investigator
Cincinnati Children's Hopital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed NIV mask in people with Sleep Apnea and Pediatric Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.