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Search / Trial NCT05454631

Tolerance of Surgical Masks in Chronic Respiratory Diseases

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 7, 2022

Trial Information

Current as of April 25, 2025

Recruiting

Keywords

Breathlessness Face Masks Covid 19 Copd Pulmonary Rehabilitation

ClinConnect Summary

This clinical trial, called the TOLMASK study, is looking at how well different types of surgical masks are tolerated by patients with chronic respiratory diseases, like Chronic Obstructive Pulmonary Disease (COPD). During the COVID-19 pandemic, wearing masks has become essential to help prevent the spread of the virus, but for people with breathing issues, wearing a mask can sometimes make it harder to breathe comfortably. The study aims to find out which mask designs are easier for these patients to wear so that healthcare providers can recommend the best options.

To participate in this study, you need to be at least 18 years old and currently receiving treatment for a respiratory condition at the Pitié-Salpêtrière Hospital. You should also be involved in a rehabilitation program that includes exercise training. However, if you have a tracheostomy, certain psychiatric disorders, or if you cannot speak French well, you may not be eligible. If you join the study, you will be asked to wear different types of masks and report how they affect your breathing and overall comfort. Your participation will help improve mask recommendations for patients with breathing difficulties.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient hospitalised in the respiratory and neuro-respiratory SSR service of the R3S department at the Pitié-Salpêtrière Hospital (Pr Gonzalez-Bermejo)
  • Patient enrolled in a respiratory rehabilitation process including exercise training on a cyclo-ergometer or treadmill
  • Hospitalization in respiratory rehabilitation unit either in post-exacerbation of COPD
  • age over 18
  • Exclusion Criteria:
  • Exercise training under mask ventilation support
  • Presence of a tracheostomy
  • Psychiatric disorders (at the discretion of the referring physician)
  • Insufficient command of the French language
  • Refusal to participate in the study

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Thomas SIMILOWSKI, MD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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