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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

3D Printer Modified CPAP Mask for Obstructive Sleep Apnea

Clinicaltrials.gov identifier NCT03932383

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted April 17, 2020

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.

  • Condition or Disease:Obstructive Sleep Apnea
  • Intervention/Treatment: Device: Custom CPAP mask
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Cohort study of intervention
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 3-D Printer Custom Modified Continuous Positive Airway Pressure Masks to Improve Efficacy and Patient Compliance in Obstructive Sleep Apnea Management
  • Actual Study Start Date: April 2018
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Modified CPAP
Single arm cohort study of modified mask
Device: Custom CPAP mask
Modified CPAP mask based on 3D image capture
Outcome Measures
  • Primary Outcome Measures: 1. Air leak time [ Time Frame: 30 day ]
    Percent of air leak time over use of mask
  • Secondary Outcome Measures: 1. CPAP mask leak volume [ Time Frame: 30 day ]
    Volume of leak recorded on CPAP machine
  • 2. Epworth Sleepiness Scale [ Time Frame: 30 day ]
    Sleepiness score - Likelihood of falling asleep in various daytime activities. Total Score Range 0-24.
  • 3. Apnea Hypopnea Index [ Time Frame: 30 day ]
    Apnea Hypopnea Index (events/hour)
  • 4. CPAP Inspiratory pressure [ Time Frame: 30 day ]
    Inspiratory pressure setting on CPAP machine (cm H2O)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator: Chee ChunMin, MD Beth Israel Deaconess Medical Center

More Information
  • Responsible Party: Beth Israel Deaconess Medical Center
  • ClinicalTrials.gov Identifier: NCT03932383 History of Changes
  • Other Study ID Numbers: 2018P000100
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 17, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive