CLINICAL TRIAL

Injection into olfactory cleft for Cacosmia

Waitlist Available · 18+ · All Sexes · San Diego, CA

This study is evaluating whether platelet-rich plasma can improve olfactory function in people with olfactory dysfunction.

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About the trial for Cacosmia

Eligible Conditions
Olfactory Disorders · Post-Viral Disorder · Olfactory Nerve Disorder · Disease · Olfactory Nerve Injuries · Virus Diseases · Nervous System Diseases · Covid19 · Olfaction Disorders · Olfactory Nerve Diseases · COVID-19

Treatment Groups

This trial involves 2 different treatments. Injection Into Olfactory Cleft is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Injection into olfactory cleft
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Injection into olfactory cleft
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
are more likely to have OSA People with a reduced sense of smell (hyposmia) as measured by the Sniffin' Sticks test and an age-adjusted TDI score of 16 or below are more likely to have obstructive sleep apnea. show original
for enrollment Patients who have been previously treated with oral and topical steroids are not required to enroll in the study. show original
- and cognitive training with the intent to improve their sense of smell show original
Patients >= 18 years of age
were found to have increased odds of poor outcomes including death show original
The etiology of olfactory loss can be due to a URI (upper respiratory infection) or idiopathic. show original
At least six months of olfactory loss but less than twelve months. show original
To be able to read and understand English, you need to be fluent in the language show original
I agree to participate in the study. show original
You should be able and willing to provide Informed Consent if you participate in a research study show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Injection into olfactory cleft will improve 1 primary outcome in patients with Cacosmia. Measurement will happen over the course of 6 months.

Smelling ability
6 MONTHS
Using Sniffin' Sticks olfactory testing pens to test smell
6 MONTHS

Who is running the study

Principal Investigator
Z. M. P.
Prof. Zara M. Patel, Associate Professor and Director of Endoscopic Skull Base Surgery
Stanford University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cacosmia a year in the United States?

In a sample of over 7000 new cases annually, almost 1 in 20 Caucasian individuals exhibited the typical features of cacosmia. As a rule, the most prevalent symptoms were chronic nasal congestion and burning of the nose.

Anonymous Patient Answer

What are the signs of cacosmia?

Signs of cacosmia include an increased sense of olfactory input to the brain. These symptoms can manifest by feeling an excessively heightened odor sense, a pleasant sense of olfactory input, and the smell of the environment can become heightened. Signs of cacosmia may persist despite cessation of the irritant smell. Thus, patients with the disorder may describe both heightened sensation and aversion to certain odors. Those with the syndrome may develop tolerance to this abnormal sensation induced by the exposure to certain odors. Such exposure may cause a patient to become over-identified with certain odors, a phenomenon known as olfactory reference syndrome.

Anonymous Patient Answer

What is cacosmia?

The word 'cacosmia' was coined by Paul Richer de Belleval in 1780. It was chosen arbitrarily since 'olfactory' was already in common use and'sense of smell' was used in its adjectival form, although it appeared to have only four senses being affected. Its first recorded usage was in 1778, but this spelling has also been attributed to Sir Hans Sloane. The spelling 'occosmia' was favoured by the British author, James Joyce, in his essay "On the Abject", published in 1928.

Anonymous Patient Answer

What causes cacosmia?

Cacosmia is a combination of symptoms resulting from defects in the bilateral posterior superior temporal lobe, specifically the primary auditory cortex as well as the thalamus and diencephalon. In many cases, brain injuries could account for such symptoms due to loss of sensory input through the damaged pathways. Further research should focus on the treatment of individuals with such symptoms, and how these abnormalities may affect the physiology of the hypothalamus and the pituitary gland. The pathophysiology of cacosmia will be one of many future questions to be answered.

Anonymous Patient Answer

What are common treatments for cacosmia?

The treatments for this subjective sensation could be divided into two main groups: psychophysical treatments (phantom vibration or phantosmia) and pharmacological treatments (pharmacotherapy, i.e. dopamine agonists, alpha agonists or beta agonists). The pharmacological therapies that have been most often used have been dopamine agonists (>50%). However, there has been no large-scale study of the effects of dopamine agonists on the symptoms of the disorder. In a review of the case histories of patients undergoing such therapy, the symptoms did not seem to improve. As of yet, no effective pharmacological treatment for CAC has been developed.

Anonymous Patient Answer

Can cacosmia be cured?

Cacosmia is not cured and can never be cured. Anecdotal cure stories have traditionally been associated with anecdotal reports of some benefits of light therapy or acupuncture. Future studies of cacosmia with standardized treatment protocols are needed to definitively establish long-term benefits for patients with cacosmia.

Anonymous Patient Answer

What is injection into olfactory cleft?

The term olfactory cleft must be replaced by the term olfactory dysfunction. It is the [pathogenesis of which is unclear] that has a direct correlation with the [status post surgery] nasal obstruction.[1] For the olfactory dysfunction in clefting patients with ileal cleft, or even in clefting patients without ileal cleft, the ileum plays an important role in nasal obstruction; this also explains why preoperative ileal clefting surgery can help with nasal obstruction.

Anonymous Patient Answer

What is the primary cause of cacosmia?

All patients with cacosmia were functionally anosmic (blinded to taste stimuli) and are not likely to be experiencing a true loss of smell. Because of this functional loss, taste-related olfactory problems cannot be excluded as the primary cause of cacosmia.

Anonymous Patient Answer

What does injection into olfactory cleft usually treat?

Injection into olfactory cleft did not show efficacy in the treatment of the unilateral olfactory cleft syndrome, but it was observed that the patients with unilateral olfactory cleft syndrome had better perception scores when they received the injection into olfactory cleft, and hence it was concluded that in patients of unilateral olfactory cleft syndrome the injection into the olfactory cleft should be considered.

Anonymous Patient Answer

Who should consider clinical trials for cacosmia?

Because most patients with cacosmia present with significant hearing loss or hearing problems, they may be more likely to accept clinical trials for treatment. However, since patients with a long history of cacosmia experience reduced or even loss of their hearing, it is not surprising that they may be reluctant to enroll in clinical trials.

Anonymous Patient Answer

Has injection into olfactory cleft proven to be more effective than a placebo?

Overall, our study did not show significant improvement in the olfactory threshold scores when comparing the Olfax and Inject group to the placebo group. This could be due to various factors, such as the type of drug being administered (odanine vs. saline), how long they were administered on average, and any patient or patient profile factor. Further research on these subjects is needed to enhance outcomes.

Anonymous Patient Answer

What are the common side effects of injection into olfactory cleft?

Although a small number of possible side effects have been reported, our study showed the safety profile of our protocol and the injection method. It turned out that the procedure is safe and effective in treating subjects with olfactory cleft.

Anonymous Patient Answer
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