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Trial - NCT04598763


Column Value
Trial registration number NCT04598763
Full text link
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04598763

First author
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Julie Lecomte

Contact
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

ju.lecomte@chru-nancy.fr

Registration date
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

2020-10-22

Recruitment status
Last imported at : Sept. 30, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: major patient patient with a sudden loss of smell> 5 weeks linked to a viral infection (including sars-cov-2) of the upper respiratory tract treated in the ent department of the chru nancy patient accepting olfactory rehabilitation patient presenting with hyposmia or anosmia (confirmed by the threshold and identification tests of the sniffin 'stick kit) patient affiliated to a social security scheme or beneficiary of such a scheme patient who has received full research information and signed an informed consent.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

persons referred to in articles l. 1121-5 to l. 1121-8 and l1122-2 of the public health code: pregnant woman, parturient or nursing mother person deprived of liberty by a judicial or administrative decision, person undergoing psychiatric treatment under articles l.3212-1 and l.3213-1 of the public health code minor (non-emancipated) adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) adult person unable to express consent and who is not the subject of a legal protection measure qualitative smell disorder (cacosmia, hyperosmia, phantosmia, parosmia) neurological, post-traumatic, neurodegenerative, congenital odor disorders post-infectious loss of smell> 12 months

Number of arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Central Hospital, Nancy, France

Inclusion age min
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

improvement in smell

Notes
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Classic", "treatment_id": 919, "treatment_name": "Olfactory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Intensive", "treatment_id": 919, "treatment_name": "Olfactory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}]