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Trial - NCT05384561


Column Value
Trial registration number NCT05384561
Full text link
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Johannes A Frasnelli, PhD

Contact
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

johannes.a.frasnelli@uqtr.ca

Registration date
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

2022-05-20

Recruitment status
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: patient diagnosed positive for covid-19 with persistent olfactory dysfunction willing and able to provide written informed consent understand and read the french language have an internet connection and a working email address

Exclusion criteria
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

anosmia and hyposmia pre-covid-19 be known chronic rhinosinusitis with or without nasal polyposis have received radiotherapy or chemotherapy for head and neck tumors have a diagnosis of alzheimer's, parkinson's, multiple sclerosis or any other neurodegenerative disease 5. have a brain tumor or ent diagnosis 6. history of naso-sinus surgery; 7. history of traumatic brain injury

Number of arms
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Université du Québec à Trois-Rivières

Inclusion age min
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

105

primary outcome
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Changes from baseline in olfactory score on the Sniffin's Sticks test;Changes from baseline in olfactory score on the University of Pennsylvania Identification Test (UPSIT) [ Time Frame: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention);n-house test for chemosensory dysfunction (TMSC);Parosmia and phantosmia assessment test;The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS)

Notes
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, Orange, and eugenol, for a total of five minutes per session.", "treatment_id": 2486, "treatment_name": "Chemosensory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "For 12 weeks, morning and evening, smell four odors namely coffee aroma, cheese aroma, strawberries, and limon, for a total of five minutes per session.", "treatment_id": 2486, "treatment_name": "Chemosensory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "For 12 weeks, morning and evening, smell four same odorless substance.", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]