NCT02896751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
Last Updated

October 3, 2025

Status Verified

August 1, 2023

Enrollment Period

5.6 years

First QC Date

September 7, 2016

Last Update Submit

September 30, 2025

Conditions

Sleep ApneaPediatric Sleep Apnea

Keywords

CPAPNoninvasive Ventilation Mask

Outcome Measures

Primary Outcomes (1)

  • CPAP Adherence

    Measure CPAP usage

    6 months

Study Arms (1)

3D Printed NIV Mask

EXPERIMENTAL

3D imaging and use of a custom mask from 3D printer

Device: 3D printed NIV mask

Interventions

3D printed NIV maskDEVICE

use of 3D printed mask

3D Printed NIV Mask

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • New diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Narong Simakajornboon, MD

    Cincinnati Children's Hopital Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

August 1, 2016

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

October 3, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Data will be shared with treating sleep physicians to improve care

Shared Documents
CSR
Time Frame
Data will be shared with treating sleep physicians to improve care
Access Criteria
Data will be shared with treating sleep physicians to improve care

Locations

US(1)