NCT03932383

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

February 21, 2019

Last Update Submit

April 16, 2020

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Air leak time

    Percent of air leak time over use of mask

    30 day

Secondary Outcomes (4)

  • CPAP mask leak volume

    30 day

  • Epworth Sleepiness Scale

    30 day

  • Apnea Hypopnea Index

    30 day

  • CPAP Inspiratory pressure

    30 day

Study Arms (1)

Modified CPAP

EXPERIMENTAL

Single arm cohort study of modified mask

Device: Custom CPAP mask

Interventions

Custom CPAP maskDEVICE

Modified CPAP mask based on 3D image capture

Modified CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Chee ChunMin, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort study of intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

April 30, 2019

Study Start

April 4, 2018

Primary Completion

December 31, 2020

Study Completion

July 1, 2021

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

US(1)