TOLMASK: Tolerance of Surgical Masks in Chronic Respiratory Diseases

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05454631

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The study is conducted in the context of the COVID-19 pandemic in general, and more specifically in the context of the evaluation of the use of protective masks as a barrier to the spread of the virus. The wearing of masks is one of the recommended barrier measures to limit the spread of the SARS-CoV-2 virus responsible for COVID-19. It is recommended in all circumstances, and mandatory in some. Regardless of the type of mask used (noting that the so-called "surgical" masks are by far the most common), there are various disadvantages associated with wearing them. Dyspnoea (unpleasant or upsetting perception of respiratory activity) is one of these disadvantages. It can lead to reluctance to wear the mask, or to the adoption of inappropriate practices that reduce its effectiveness. This "side effect" of the mask is more pronounced in patients with underlying respiratory diseases. However, not all mask designs are equivalent in terms of their physical properties, which can theoretically generate varying levels of dyspnoea. It is therefore important to determine which mask designs are more or less dyspnogenic, in order to guide the preferential use of certain designs in certain patient categories. The TOLMASK study (Tolerance of SARS-CoV2 Surgical Masks in Patients with Chronic Respiratory Diseases) is a prospective, randomised, triple-blind, single-centre study comparing several surgical masks in a crossover design. The primary objective of the study is to evaluate the respiratory tolerance of different surgical masks and the secondary objective is to evaluate their general tolerance.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: surgical mask (5 different types)	N/A

Detailed Description

The study was conducted in the context of the COVID-19 pandemic in general, and more specifically in the context of the evaluation of the use of protective masks as a barrier to the spread of the virus. The wearing of masks is one of the recommended barrier measures to limit the spread of the SARS-CoV-2 virus responsible for COVID-19. It is recommended in all circumstances, and mandatory in some. Regardless of the type of mask used (noting that the so-called "surgical" masks are by far the most common), there are various disadvantages associated with wearing them. Dyspnoea (unpleasant or worrying perception of respiratory activity) is one of these disadvantages. It can lead to reluctance to wear the mask, or to the adoption of inappropriate practices that reduce its effectiveness. This "side effect" of the mask is more pronounced in patients with underlying respiratory diseases. However, not all mask designs are equivalent in terms of their physical properties, which can theoretically generate varying levels of dyspnoea. It is therefore important to determine which mask designs are more or less dyspnogenic, in order to guide the preferential use of certain designs in certain patient categories. The TOLMASK study (Tolerance of SARS-CoV2 Surgical Masks in Patients with Chronic Respiratory Diseases) is a prospective, randomised, triple-blind, single-centre study comparing several surgical masks in a crossover design. The primary objective of the study is to evaluate the respiratory tolerance of different surgical masks and the secondary objective is to evaluate their general tolerance.

The inclusion criteria are : 1) patient hospitalised in the respiratory and neuro-respiratory rehabilitation department of the R3S department at the Pitié-Salpêtrière Hospital (Pr Gonzalez-Bermejo); 2) patient enrolled in a respiratory rehabilitation process including exercise training on a cyclo-ergometer or treadmill; 3) hospitalisation in the respiratory rehabilitation department either post-exacerbation of COPD (usual recruitment of the department) or post-COVID (depending on the epidemic situation at the time of the study); 4) patient of age.

The criteria for non-inclusion are 1) Exercise re-training under mask ventilatory assistance; 2) Presence of a tracheotomy; 3) Psychiatric disorders (at the discretion of the referring physician); 4) Insufficient command of the French language; 5) Refusal to participate in the study.

50 patients will be included, over a period of 4 months. The duration of participation is 5 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

not everyone involved in the research (patients, investigators, caregivers, and statistical analysis stakeholders) will know which mask the patient is using at which time.

Primary Purpose:

Other

Official Title:

Satisfaction Survey on the Tolerability of Surgical Masks for Protection Against the Spread of SARS-CoV2 in Patients With Chronic Respiratory Diseases

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patient present at the respiratory SSR department of the Pitié-Salpêtrière hospital All the participants will evaluate 5 different types of surgical mask, in random order.	Device: surgical mask (5 different types) All the participants will wear 5 different types of surgical mask, in random order.

Arm

Intervention/Treatment

Experimental: patient present at the respiratory SSR department of the Pitié-Salpêtrière hospital

All the participants will evaluate 5 different types of surgical mask, in random order.

Device: surgical mask (5 different types)

All the participants will wear 5 different types of surgical mask, in random order.

Outcome Measures

Primary Outcome Measures

affective dimension of dyspnea [immediately after a rehabilitation session]
Intensity of the sensory dimension of respiratory discomfort attributed to wearing the mask during exercise training, assessed on an 11-point ordinal scale (from "0, the mask caused no particular respiratory sensation" to "10, the mask caused a respiratory sensation as intense as I can imagine")

Secondary Outcome Measures

sensory dimension of dyspnea [immediately after a rehabilitation session]
Intensity of the sensory dimension of respiratory discomfort attributed to wearing the mask during exercise training, assessed on an 11-point ordinal scale (from "0, the mask caused no particular respiratory sensation" to "10, the mask caused a respiratory sensation as intense as I can imagine")
relief [immediately after a rehabilitation session]
Intensity of relief on mask removal, rated on an 11-point ordinal scale (from "0, mask removal caused no relief" to "10, mask removal caused absolute relief")
MDP (Multidimensional Dyspnea Profile) [immediately after a rehabilitation session]
Response to the Multidimensional Dyspnea Profile questionnaire (French version) The Multidimensional Dyspnoea Profile (MDP) consists of eleven 0-10 numerical rating scales describing the unpleasantness of dyspnea (A1, maximum score of 10), its sensory qualities (5 items [SQ], maximum 50), and its emotional qualities (5 items [A2], maximum 50).
general comfort [immediately after a rehabilitation session]
Overall comfort of the mask tested, rated on an 11-point ordinal scale (from "0, this mask is horribly uncomfortable", to "10, this mask is perfectly comfortable").
choice [immediately after a rehabilitation session]
Overall comfort of the mask tested, rated on Choice and ranking of 5 mask disadvantages from a list of 15 In addition, at the end of the study, patients will be asked to indicate which of the masks tested they preferred.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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