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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 |
|
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"}] |