Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
NCT02896751 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-10-03
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.
Conditions
- Sleep Apnea
- Pediatric Sleep Apnea
Interventions
- DEVICE
-
3D printed NIV mask
use of 3D printed mask
Sponsors & Collaborators
-
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Narong Simakajornboon, MD · Cincinnati Children's Hopital Medical Center
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2022-03-07
- Completion
- 2022-03-07
Countries
- United States
Study Locations
More Related Trials
-
The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
NCT02816255 ·Status: TERMINATED ·Phase: NA
-
Assessment of Circuit Rebreathing During CPAP Therapy
NCT07062770 ·Status: RECRUITING ·Phase: NA
-
Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome
NCT04925739 ·Status: COMPLETED
-
Continuous Positive Airway Pressure and Cardiometabolic Risk
NCT01403194 ·Status: TERMINATED ·Phase: NA
-
Multinight CPAP for Sleep Apnea Patients
NCT02635100 ·Status: TERMINATED ·Phase: NA
-
Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome
NCT01768065 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care
NCT02781376 ·Status: COMPLETED ·Phase: NA
-
Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy
NCT03011762 ·Status: COMPLETED ·Phase: NA
-
Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients
NCT01556464 ·Status: WITHDRAWN ·Phase: NA
-
cNEP for the Treatment of Obstructive Sleep Apnea
NCT02677168 ·Status: COMPLETED ·Phase: NA
-
Nasal and Oronasal Mask in Severe OSA Patients With Nasal Free Airflow of Obstruction
NCT02274194 ·Status: COMPLETED ·Phase: NA
-
Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)
NCT01156649 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP
NCT01909674 ·Status: COMPLETED ·Phase: NA
-
Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP
NCT02217397 ·Status: UNKNOWN ·Phase: NA
-
The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
NCT07176767 ·Status: RECRUITING
-
Trans Nasal Insufflation for the Treatment of Snoring
NCT00832026 ·Status: COMPLETED
-
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
NCT01312948 ·Status: COMPLETED ·Phase: NA
-
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
NCT02972970 ·Status: COMPLETED ·Phase: NA
-
Pilot Study of cNEP for the Treatment of Snoring
NCT02767843 ·Status: TERMINATED ·Phase: NA
-
Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea
NCT03782844 ·Status: COMPLETED ·Phase: NA
-
Airway Muscle Activation on Sleep-disordered Breathing Events
NCT06002061 ·Status: RECRUITING ·Phase: NA
-
Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment
NCT01939938 ·Status: COMPLETED ·Phase: NA
-
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
NCT02324790 ·Status: TERMINATED ·Phase: NA
-
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
NCT04712656 ·Status: RECRUITING
-
Comparison of a Demand Oxygen Delivery
NCT06609694 ·Status: RECRUITING ·Phase: NA