Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status and phase: Withdrawn; Phase 4

Conditions: Olfactory Disorder

Treatments: Drug: corticosteroid nasal irrigation; Other: Olfactory retraining; Other: smell household Items; Other: Nasal Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04374474

Anosmia_CoVID 19

Details and patient eligibility

About

The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18 years of age or older
• Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
• Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.

Exclusion criteria

• active cigarette smoker
• chronic rhinosinusitis
• head trauma with loss of consciousness
• inability to read/understand English
• previous hyposmia/anosmia complaint
• pregnancy
• previous sinus
• skull base or brain surgery
• current participation in another clinical trial at the time of initial visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Control Group

Sham Comparator group

Description:

The participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day.

Treatment:

Other: Nasal Irrigation

Other: smell household Items

Olfactory Retraining Group

Experimental group

Description:

The participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day.

Treatment:

Other: Nasal Irrigation

Other: Olfactory retraining

Olfactory Retraining_Budesonide Group

Experimental group

Description:

The participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day.

Treatment:

Other: Olfactory retraining

Drug: corticosteroid nasal irrigation