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3D Printer Modified CPAP Mask for Obstructive Sleep Apnea (3DCPAP)

Primary Purpose

Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom CPAP mask
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of obstructive sleep apnea prescribed CPAP
  • High air leak:1. Absolute high leak duration more than 15% of the use period and / or 2. Absolute high leak over 5% associated with periodic breathing.

Exclusion Criteria:

  • Unable to wear full face CPAP
  • Unable to provide informed consent

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified CPAP

Arm Description

Single arm cohort study of modified mask

Outcomes

Primary Outcome Measures

Air leak time
Percent of air leak time over use of mask

Secondary Outcome Measures

CPAP mask leak volume
Volume of leak recorded on CPAP machine
Epworth Sleepiness Scale
Sleepiness score - Likelihood of falling asleep in various daytime activities. Total Score Range 0-24.
Apnea Hypopnea Index
Apnea Hypopnea Index (events/hour)
CPAP Inspiratory pressure
Inspiratory pressure setting on CPAP machine (cm H2O)

Full Information

First Posted
February 21, 2019
Last Updated
April 16, 2020
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03932383
Brief Title
3D Printer Modified CPAP Mask for Obstructive Sleep Apnea
Acronym
3DCPAP
Official Title
3-D Printer Custom Modified Continuous Positive Airway Pressure Masks to Improve Efficacy and Patient Compliance in Obstructive Sleep Apnea Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective pilot to investigate the effect of 3D printer customized CPAP masks on the comfort of patients with obstructive sleep apnea.
Detailed Description
Purpose: The purpose of this protocol is to perform a prospective pilot clinical study to customize patient CPAP masks to reduce air leak in patients with obstructive sleep apnea (OSA). Using 3-D printer-based technology modeling of patient facial features, patient FDA-approved CPAP masks will be modified by strategically applying silicone pads on the CPAP mask to mold to the specific facial features to optimize the CPAP mask-patient interface, improve CPAP mask fit and comfort, reduce air leak, limit air pressure loss and improve compliance with CPAP treatment strategy (as measured over a 30 day trial period). Protocol: Potential subjects for this study will be identified at the outpatient Sleep Disorders Clinic at BIDMC. Patients will have documented OSA, prescribed CPAP as standard-of-care, and demonstrate consistent problems with CPAP mask-patient interface with documented high air loss, and poor adherence/ compliance. All potential subjects will have used and will continue to use an FDA-approved CPAP mask selected by the patient. Potential subjects (along with their FDA-approved CPAP mask) will then be referred to the BIDMC Specialties Clinic and screened, including review of the medical history of OSA, review of documented reports of excessive air leak and suboptimal adherence to CPAP, brief physical exam (esp. focusing on the head-and-neck exam) including assessment of the CPAP mask-patient interface, review of the purpose and goals of the pilot clinical study, a dynamic video of the study subject face will be performed, video downloaded to a computer which will then be used to generate a 3-dimensional plastic model of the study subject face using state-of-the-art 3D printer technology (see details below). The patient's FDA-approved CPAP mask will then be applied to his plastic model of the study subject face, and the CPAP mask modified with the application of silicon pads along the mask pillow cushion to optimize the CPAP mask-face model interface, primarily by adjustments to improve CPAP mask contact with the face model and limit the air leak during CPAP ventilation. Once the patient's FDA-approved CPAP mask has been modified, the patient will then return to the BIDMC Specialties Clinic for a final fitting of the modified CPAP mask, with additional adjustments (as necessary) made to optimize the CPAP mask-patient interface. The study subject will then return home with his/her custom-modified CPAP mask to use as prescribed. Standard home monitoring and recording of use of the modified CPAP mask will be performed per usual case over a 30-day period. Data obtained during this 30-day period will focus on the duration of use of the modified CPAP mask, measurement of air leak and pressure loss, report of patient comfort and experience with the modified CPAP mask, and compare to data over a 30 day period using the CPAP mask prior to modification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort study of intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified CPAP
Arm Type
Experimental
Arm Description
Single arm cohort study of modified mask
Intervention Type
Device
Intervention Name(s)
Custom CPAP mask
Intervention Description
Modified CPAP mask based on 3D image capture
Primary Outcome Measure Information:
Title
Air leak time
Description
Percent of air leak time over use of mask
Time Frame
30 day
Secondary Outcome Measure Information:
Title
CPAP mask leak volume
Description
Volume of leak recorded on CPAP machine
Time Frame
30 day
Title
Epworth Sleepiness Scale
Description
Sleepiness score - Likelihood of falling asleep in various daytime activities. Total Score Range 0-24.
Time Frame
30 day
Title
Apnea Hypopnea Index
Description
Apnea Hypopnea Index (events/hour)
Time Frame
30 day
Title
CPAP Inspiratory pressure
Description
Inspiratory pressure setting on CPAP machine (cm H2O)
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of obstructive sleep apnea prescribed CPAP High air leak:1. Absolute high leak duration more than 15% of the use period and / or 2. Absolute high leak over 5% associated with periodic breathing. Exclusion Criteria: Unable to wear full face CPAP Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chee ChunMin, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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3D Printer Modified CPAP Mask for Obstructive Sleep Apnea

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