10
Participants
Start Date
December 10, 2023
Primary Completion Date
April 30, 2024
Study Completion Date
May 31, 2024
3d printed mask
"* Concurrent, prospective, non-randomized inclusion, cross-over design. A minimum of 6 patients will be included for each group, COPD, and ALS.~* T0: Patient enrollment (informed consent signing), retrospective review of the respirator log (1 month prior), variable extraction (extracting EDF files from the respirator log and data obtained from ResScan).~* During the first week, a 3D scan of the patient's face will be conducted, and the personalized 3D-printed mask (M3D) will be manufactured.~* Once ready, the mask will be fitted, and the 1-month evaluation period will begin (T1: after 1 month of M3D use). The respirator card will be downloaded in the same manner as at T0, and a respiratory polygraphy (RP) will be scheduled.~* T2: At the end of the study month, the patient will resume using a similar MC, which is new and well-fitted. After one month of MC use, the respirator log will be reviewed, and a new RP will be conducted."
RECRUITING
Hospital Universitarios 12 de Octubre, Madrid
Hospital Universitario 12 de Octubre
OTHER