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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02896751
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : June 5, 2018
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Pediatric Sleep Apnea Device: 3D printed NIV mask Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Adherence Rate [ Time Frame: 6 months ]
    Change to usage of PAP (Positive Airway Pressure) treatment as measured through data downloaded from PAP machine.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • New diagnosis

Information from the National Library of Medicine

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 identifier (NCT number): NCT02896751

Contact: Geoffrey Rulong, MD 513-803-3984
Contact: Narong Simakajornboon, MD 513-636-3762

United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Geofrey Rulong, MD         
Sub-Investigator: Geofrey Rulong, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Narong Simakajornboon, MD Cincinnati Children's Hopital Medical Center

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT02896751     History of Changes
Other Study ID Numbers: CIN001-3D Printer NIV Mask
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with treating sleep physicians to improve care

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Noninvasive Ventilation Mask

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases