Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204432
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-01-10
Brief Title:
Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Efficacy of Adjunctive Sodium Citrate in Smell Retraining for People With Post-Acute Sequelae COVID-19 Olfactory Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to assess the feasibility and impact of using sodium citrate nasal spray as an adjunct to olfactory retraining in participants with long-term post-COVID-19 olfactory dysfunction
The main questions it aims to answer are
Is sodium citrate nasal spray in addition to smell retraining feasible for participants to use in terms of participant needdesire adherence and adverse events
Does sodium citrate nasal spray in addition to smell retraining further improve smell as compared to normal saline spray and smell retraining
Participants will
Provide consent for enrollment
Undergo smell testing via Sniffin Sticks
Use a nasal spray either sodium citrate or normal saline followed by olfactory retraining twice a day for 12 weeks
Return for follow-up Sniffin Sticks testing
Researchers will compare the sodium citrate group and the normal saline group to determine differences in smell improvement
The main questions it aims to answer are
Is sodium citrate nasal spray in addition to smell retraining feasible for participants to use in terms of participant needdesire adherence and adverse events
Does sodium citrate nasal spray in addition to smell retraining further improve smell as compared to normal saline spray and smell retraining
Participants will
Provide consent for enrollment
Undergo smell testing via Sniffin Sticks
Use a nasal spray either sodium citrate or normal saline followed by olfactory retraining twice a day for 12 weeks
Return for follow-up Sniffin Sticks testing
Researchers will compare the sodium citrate group and the normal saline group to determine differences in smell improvement
Detailed Description:
Background Loss of sense of smell is a hallmark of COVID-19 infection While about 80 of post-COVID olfactory dysfunction OD will experience some spontaneous recovery within 2 months of initial infection about 20 will continue to suffer long-term1 Participants with persistent OD suffer great disability including loss of pleasure with eating leading to weight loss andor gain and other health risks including possible dementia Further loss of smell may lead to harm with chief examples of inability to smell gas leaks or food that has gone bad Currently use of smell retraining is recognized internationally as the most accepted method to treat patients with OD including post-viral or post-infectious OD2 Some authors have extrapolated that smell retraining may be of benefit in post-COVID OD however data is sparse3
Increased extracellular calcium has been shown to inhibit the olfaction cascade occurring in the nose by either phosphorylating adenylate cyclase or by interacting and decreasing cyclic nucleotide-gated channels sensitivity to cyclin nucleotides Several studies have been performed to date using sodium citrate administered as a nasal spray to effectively reduce extracellular calcium resulting in temporary sense of smell benefit in those who have smell loss from a variety of causes most significantly post-viral or post-infectious loss PIOD
Several studies over the last two decades have examined the effect of sodium citrate on olfactory function in those with OD mainly post-infectious OD all of which have shown acute improvement in smell peaking typically around 1 hour after application4-7 Most recently in 2021 Whitcroft et al conducted a controlled clinical trial on 60 PIOD participants They applied sodium citrate intranasal spray to participants right nostril for two weeks and olfaction was evaluated by Sniffin Sticks composite TDI score both before the trial and after 2 weeks of sodium citrate use They found a significant improvement in TDI score though not reaching clinical significance Further while the proportion of participants reporting parosmia did not change there was a significant reduction in participants reporting phantosmia8
The hypothesis is that the administration of sodium citrate to the nasal cavity providing a temporary improvement in sense of smell before the performance of smell retraining may augment its effects and yield better recovery in post-COVID-19 OD
Purpose The goal of this pilot study is to assess the feasibility and impact of using sodium citrate nasal spray as an adjunct to olfactory retraining in participants with long-term post-COVID-19 olfactory dysfunction
Participants Adults 18 years with 3 months of subjective olfactory loss
Methods All participants will undergo initial smell testing with the University of Pennsylvania Smell Identification Test UPSIT to confirm smell loss before enrollment
Following screening and consent enrollment will involve collecting participant data such as medication allergies time between COVID-19 infection and smell loss previous smell loss therapies tried presence of gustatory dysfunction and use of paxlovid Participants olfaction will then be objectively evaluated using Sniffin Sticks a validated psychophysical tool that allows for more detailed assessment of odor threshold discrimination and identification
Participants will be randomized into two groups and blinded The Sodium Citrate arm will apply a nasal spray of sodium citrate 05 mL per nostril and then perform olfactory training exercises twice a day for 12 weeks The Normal Saline arm will apply a spray of normal saline 05 mL per nostril and then perform olfactory training exercises twice a day for 12 weeks Olfactory training will involve mindful inhalation of 4 primary odortants lavender clove eucalyptus and lemon at least 20 seconds for each
All materials will be provided by AdvancedRx who will also perform the randomization to ensure investigators are blind as well Nasal sprays will be shipped in 1-month quantities and adherence will be checked at the end of each month by assessing the amount of spray left in each bottle During the 12 weeks at days 7 28 and 56 investigators will contact the participants to discuss if any adverse events have occurred
At the end of the 12 weeks Sniffin Sticks assessment will be repeated and results compared within and between the groups Also the number of eligible participants encountered the number enrolled the number who completed the study the adherence rate and the adverse event rates will be assessed within the overarching 1 year study period
Increased extracellular calcium has been shown to inhibit the olfaction cascade occurring in the nose by either phosphorylating adenylate cyclase or by interacting and decreasing cyclic nucleotide-gated channels sensitivity to cyclin nucleotides Several studies have been performed to date using sodium citrate administered as a nasal spray to effectively reduce extracellular calcium resulting in temporary sense of smell benefit in those who have smell loss from a variety of causes most significantly post-viral or post-infectious loss PIOD
Several studies over the last two decades have examined the effect of sodium citrate on olfactory function in those with OD mainly post-infectious OD all of which have shown acute improvement in smell peaking typically around 1 hour after application4-7 Most recently in 2021 Whitcroft et al conducted a controlled clinical trial on 60 PIOD participants They applied sodium citrate intranasal spray to participants right nostril for two weeks and olfaction was evaluated by Sniffin Sticks composite TDI score both before the trial and after 2 weeks of sodium citrate use They found a significant improvement in TDI score though not reaching clinical significance Further while the proportion of participants reporting parosmia did not change there was a significant reduction in participants reporting phantosmia8
The hypothesis is that the administration of sodium citrate to the nasal cavity providing a temporary improvement in sense of smell before the performance of smell retraining may augment its effects and yield better recovery in post-COVID-19 OD
Purpose The goal of this pilot study is to assess the feasibility and impact of using sodium citrate nasal spray as an adjunct to olfactory retraining in participants with long-term post-COVID-19 olfactory dysfunction
Participants Adults 18 years with 3 months of subjective olfactory loss
Methods All participants will undergo initial smell testing with the University of Pennsylvania Smell Identification Test UPSIT to confirm smell loss before enrollment
Following screening and consent enrollment will involve collecting participant data such as medication allergies time between COVID-19 infection and smell loss previous smell loss therapies tried presence of gustatory dysfunction and use of paxlovid Participants olfaction will then be objectively evaluated using Sniffin Sticks a validated psychophysical tool that allows for more detailed assessment of odor threshold discrimination and identification
Participants will be randomized into two groups and blinded The Sodium Citrate arm will apply a nasal spray of sodium citrate 05 mL per nostril and then perform olfactory training exercises twice a day for 12 weeks The Normal Saline arm will apply a spray of normal saline 05 mL per nostril and then perform olfactory training exercises twice a day for 12 weeks Olfactory training will involve mindful inhalation of 4 primary odortants lavender clove eucalyptus and lemon at least 20 seconds for each
All materials will be provided by AdvancedRx who will also perform the randomization to ensure investigators are blind as well Nasal sprays will be shipped in 1-month quantities and adherence will be checked at the end of each month by assessing the amount of spray left in each bottle During the 12 weeks at days 7 28 and 56 investigators will contact the participants to discuss if any adverse events have occurred
At the end of the 12 weeks Sniffin Sticks assessment will be repeated and results compared within and between the groups Also the number of eligible participants encountered the number enrolled the number who completed the study the adherence rate and the adverse event rates will be assessed within the overarching 1 year study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None