Demonstrating that repeated cold exposure would improve olfactory function. It was hypothesized that high-dose WBC (five 3-min long sessions of whole body crytotherapy over 1 week) would result in more benefits that low-dose WBC (two 3-min long sessions of whole body cryotherapy over 1 week).
Design
Pilot randomized controlled trial with a parallel group design of forty-five COVID-19 recovered patients with anosmia or severe hyposmia, enrolled between February 2021 and April 2021. Olfactory function was assessed before and after intervention for each participant.
Settings and conduct
WBC sessions were conducted at the Cryotherapy Center of Bezannes, France. The day before and the day following the assigned intervention, each participant was examined by a physician who evaluated their sense of smell.
Participants/Inclusion and exclusion criteria
Participants had to be COVID-19 recovered patients with residual anosmia or severe hyposmia after diagnosis of SARS-CoV-2 infection (positive PCR test). Participants with medical contraindications to Whole-Body Cryotherapy were excluded.
Intervention groups
There were two intervention groups and one control group. In the first intervention group (high-dose WBC) participants received daily sessions (5 days over one week) of WBC. Each session was 3 minutes in length and was performed in a cryotherapy chamber exposing individuals to freezing dry air at a temperature of -90°C. In the second intervention group (low-dose WBC), the intervention was similar but participants received only two WBC sessions over one week.
Main outcome variables
Our main outcome variable was participants' score change on a Visual Analog Scale. We used a straight horizontal line of 100 mm with "0" indicating no loss of the sense of smell compared to what it was before COVID-19 infection and "100" indicating complete loss.
General information
Reason for update
Acronym
CRYOTAN
IRCT registration information
IRCT registration number:IRCT20210708051817N1
Registration date:2021-07-14, 1400/04/23
Registration timing:retrospective
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
Fabien LEGRAND
Name of organization / entity
University of Reims Champagne Ardenne
Country
France
Phone
+33 3 26 91 38 90
Email address
fabien.legrand@univ-reims.fr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-01, 1399/11/13
Expected recruitment end date
2021-05-01, 1400/02/11
Actual recruitment start date
2021-02-15, 1399/11/27
Actual recruitment end date
2021-04-19, 1400/01/30
Trial completion date
2021-05-01, 1400/02/11
Scientific title
Whole-Body Cryotherapy (WBC) for COVID-19 recovered patients having anosmia or severe hyposmia
Public title
Whole Body Cryotherapy (WBC) for treating anosmia / hyposmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
recovered COVID-19 patients (asymptomatic for at least 3 weeks)
anosmia or severe hyposmia (more than 50 percent reduction of olfactory acuity)
Exclusion criteria:
medical contraindications to Whole-Body Cryotherapy
Age
From 18 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
A permutated block randomization design at the level of the individual was used, with a block size of three individuals. In each block of three, two patients were randomly assigned to the experimental groups (low-dose WBC, high-dose WBC) and one patient to the control group. This was done using sealed envelops. There was no allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Société Française de Cryothérapie Corps Entier
Street address
11 avenue du Tremblay
City
Paris
Postal code
75012 Paris
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
SFCCE-2021-3
Health conditions studied
1
Description of health condition studied
COVID-19 induced anosmia or severe hyposmia (defined as more than 50 percent of loss of sense of smell)
ICD-10 code
U07.1
ICD-10 code description
U07.1 COVID-19, virus identified
Primary outcomes
1
Description
participant's score change on the Visual Analog Scale measuring the loss of sense of smell
Timepoint
the day before and the day following intervention
Method of measurement
participant's self-report evaluation on a Visual Analog Scale 0-100 ; with "0" indicating complete loss of sense of smell compared to what it was before being infected by COVID-19; and"100" indicating full recovery of sense of smell.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: high-dose Whole-Body Cryotherapy (WBC). Participants receive daily sessions of WBC in a cryotherapy chamber at temperature of -90°C. Sessions are 3 minutes in length. Intervention's duration is 5 days.
Category
Treatment - Other
2
Description
Intervention group 2: low-dose Whole-Body Cryotherapy (WBC). Participants receive daily sessions of WBC in a cryotherapy chamber at temperature of -90°C. Sessions are 3 minutes in length. Intervention's duration is 2 days.
Category
Treatment - Other
3
Description
Control group: participants in the control group received no WBC sessions
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cryotherapy Center "CRYOTERA"
Full name of responsible person
Bastien Bouchet
Street address
7 rue Jules Méline
City
Bezannes
Postal code
51430
Phone
+33 3 26 77 97 50
Email
bastien.bouchet@cryotera.fr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Reims Champagne Ardenne
Full name of responsible person
Fabien Legrand
Street address
9 Boulevard de la Paix
City
Reims
Postal code
51100
Phone
+33 3 26 91 38 90
Email
fabien.legrand@univ-reims.fr
Grant name
non pharmacological interventions
Grant code / Reference number
NPI-2021-2
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Reims Champagne Ardenne
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Reims Champagne Ardenne
Full name of responsible person
Fabien Legrand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
9 Boulevard de la Paix
City
Reims
Province
Grand Est
Postal code
51100
Phone
+33 3 26 91 38 90
Email
fabien.legrand@univ-reims.fr
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Reims Champagne Ardenne
Full name of responsible person
Guillaume Polidori
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Technology Assessment
Street address
9 Boulevard de la Paix
City
Reims
Province
Grand Est
Postal code
51100
Phone
+33 3 26 91 38 90
Email
guillaume.polidori@univ-reims.fr
Person responsible for updating data
Contact
Name of organization / entity
Société Française de Cryothérapie Corps Entier
Full name of responsible person
Bastien Bouchet
Position
Manager
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
11 avenue du Tremblay
City
Paris
Province
Ile de France
Postal code
75012 Paris
Phone
+33 1 41 74 43 56
Email
bastien.bouchet@cryotera.fr
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we will provide all collected deidentified participants' data set in a .xls file
When the data will become available and for how long
data set will be available as of 1 September 2021 for one full year
To whom data/document is available
data set will be available for people working in academic institutions
Under which criteria data/document could be used
data can be used for scientific purposes
From where data/document is obtainable
person to be contacted: fabien.legrand@univ-reims.fr
What processes are involved for a request to access data/document
write an email explaining what for you might need the data set