Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2022-03-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Olfactory Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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.

Group Type SHAM_COMPARATOR

smell household Items

Intervention Type OTHER

Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items

Nasal Irrigation

Intervention Type OTHER

Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.

Olfactory Retraining Group

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.

Group Type EXPERIMENTAL

Olfactory retraining

Intervention Type OTHER

Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.

Nasal Irrigation

Intervention Type OTHER

Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.

Olfactory Retraining_Budesonide Group

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.

Group Type EXPERIMENTAL

Olfactory retraining

Intervention Type OTHER

Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.

corticosteroid nasal irrigation

Intervention Type DRUG

Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA).

Interventions

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Olfactory retraining

Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.

Intervention Type OTHER

corticosteroid nasal irrigation

Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA).

Intervention Type DRUG

smell household Items

Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items

Intervention Type OTHER

Nasal Irrigation

Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.

Intervention Type OTHER

Other Intervention Names

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essential oils kit smell training Budesonide nasal irrigation Nasal Rinse

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No