ParosmiaPhase 3StellaNCT06055270
Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia
A Phase 3 study testing Stellate Ganglion Block in people with Parosmia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis, affecting up to 1.2 million people in the United States. Olfactory dysfunction significantly impacts one's quality of life by decreasing the enjoyment of foods, creating environmental safety… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parosmia
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2024to 15 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 to 70
- Diagnosis of COVID-19 at least 6 months prior to study enrollment with self-reported parosmia
- Ability to read, write, and understand English
- Score of at least 15 on DiSODOR
Who cannot join
- History of smell loss or change prior to COVID-19 infection
- History of conditions known to impact olfactory function:
- Chronic rhinosinusitis
- History of prior sinonasal or skull base surgery
- Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)
- Currently using concomitant therapies specifically for the treatment of olfactory dysfunction
Show all 16Show fewer
- Inability to tolerate a needle injection into the neck
- History of coexisting conditions that make SGB contraindicated:
- Unilateral vocal cord paralysis
- Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted)
- Recent myocardial infarction within the last year
- Glaucoma
- Cardiac conduction block of any degree
- Currently taking blood thinners or antiplatelet agents
- Allergy to local anesthetic
- Inability to extend the neck for any reason (e.g., severe arthritis)
Trial locations and contacts
1 site in 1 country.
Cristian Dihel, MD contact
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital London
London, Ontario, N6A 4V2
Michal Kahanovitch, MsC, 5196466100 ext. 61125, michal.kahanovitch@sjhc.london.on.ca
Leigh sowerby, MD, MHM, FRCSC
About this study
Official title: Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia: Double-Blinded, Placebo-Controlled Randomized Clinical Trial
Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis, affecting up to 1.2 million people in the United States. Olfactory dysfunction significantly impacts one's quality of life by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform specific jobs. Olfactory loss is also an independent predictor of anxiety, depression, and mortality.
Recent research suggests that parosmia, more so than hyposmia, can increase anxiety, depression, and even suicidal ideation. While the pandemic has advanced the scientific community's interest in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or "Long COVID" symptoms, have been hypothesized to result from sympathetic nervous system dysfunction. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies before the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted in modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality of life, but it lacked a control group.
Therefore, we propose a double-blinded, placebo-controlled, randomized clinical trial assessing the efficacy of a stellate ganglion block with Lidocaine versus saline injection in up to 50 participants with persistent COVID-19-associated olfactory dysfunction.
Read the detailed description
This will be a double-blinded, placebo-controlled, randomized clinical to assess the efficacy of Stellate Ganglion Block with Lidocaine 1% (8mL). Participants with parosmia will be randomly assigned to SGB with Lidocaine 1% (8mL) or Placebo (saline solution). Baseline assessment will happen in person and will consist on demographic information, Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR), Clinical Global Impression: Severity Scale (CGI-S), University of Pennsylvania Smell Identification Test (UPSIT), Long-COVID Questionnaire (LCQ), Olfaction Catastrophizing Scale (OCS), Hospital Anxiety and Depression Scale (HADS), Pre-Intervention Expectations. Then, after the assigned interventional procedures are performed three remote visits will be performed as follow-ups (1, 3, and 12 months), in which the variables above will be reassessed.
- Conditions
- Parosmia
- Being tested
- Stellate Ganglion Block, Placebo
- Keywords
- Long-COVID, Olfactory disfunction, smell, olfaction, anosmia, bad smell
- Medical subject headings
- Olfaction Disorders, Post-Acute COVID-19 Syndrome, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
Also called SGB, sympathetic block
All SGBs will be performed by a board-certified anesthesiologist and pain management specialist with extensive experience performing SGBs. The laterality of the SGB will be randomized between the left and right sides of the neck. Participants will be asked to abstain from eating and drinking for 8 hours prior to the SGB. Using ultrasound guidance, the transverse process of the C6 vertebra is identified. Color-doppler is used to identify blood vessels. A 27-gauge needle is used to anesthetize the superficial skin with 1% lidocaine. Then, a 21-gauge ultrasound needle is advanced using an in-plane technique from lateral to medial with careful avoidance of neurovascular structures. After negative aspiration, 8 mL of 1% Lidocaine is deposited beneath the prevertebral fascia and above the Longus coli muscle into the stellate ganglion.
PlaceboOther
Also called Placebo sham injection
The placebo sham injection will be performed in an identical fashion as the stellate ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | The placebo sham injection will be performed in an identical fashion as the stellate ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of Lidocaine. Receives: Other: Placebo |
| Stellate Ganglion Block | Experimental | The ultrasound-guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB. Receives: Procedure: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)
The DisODOR is a disease-specific questionnaire that assesses for physical problems, functional limitations, and emotional consequences of parosmia secondary to any etiology. The instrument contains 29 total items with each scored on a 5-point Likert scale from 0 to 4. The minimal clinically important difference (MCID) for the instrument is 15.
Measured: Baseline, 1, 3, and 12 months after SGB
Secondary outcomes (9)
Clinical Global Impression - Severity Scale (CGI-S)
The baseline severity of parosmia will be measured with the CGI-S scale. The CGI-S scale measures disease severity in clinical condition based on a 5-point Likert scale.
Measured: Baseline
Clinical Global Impression - Improvement Scale (CGI-I)
The overall response to treatment will be measured with the CGI-I scale. The CGI-I Scale measures response to treatment for a number of disorders and has good internal consistency and validity.32 The CGI-I scale measures change in clinical condition based on a 7-point Likert scale. The CGI-I for parosmia asks, "Compared to before your stellate ganglion block, how would you describe your parosmia (things do not smell the same as you remember)?" Response options for each are: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Responders are defined as those who report "slightly better now than before" or greater.
Measured: 1, 3, and 12 months after SGB
University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey).
The UPSIT is a test of olfactory identification and consists of four 10-page booklets, with a total of 40 items. On each page, there is a different "scratch and sniff" strip and four choice options. Subjects are asked to scratch each strip with a pencil to release the scents, detect the smell, and identify the smell from the four choice options. The UPSIT comes from a scoring rubric that identifies the normalcy benchmark based on age and gender, which is >34 in women and >33 in men.33,34 The UPSIT is commercially available, takes 10-15 minutes to complete, and is the gold standard test to assess smell identification. The minimal clinically important difference of the UPSIT is 4.
Measured: Baseline
Long-COVID Questionnaire (LCQ)
Symptoms assessed via the LCQ are derived from the Symptom Burden Questionnaire for Long Covid35, which included tiredness/fatigue, shortness of breath, brain fogginess, headache, cough, depression, low-grade fevers, palpitations, dizziness, muscle pain, and joint pains. At baseline, participants are asked to rank the current severity of each problem on a 5-point Likert scale. At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.
Measured: Baseline, 1, 3, and 12 months after SGB
Olfaction Catastrophizing Scale (OCS)
The pain catastrophizing scale (PCS) was developed to measure the negative mental response to actual or anticipated pain. The OCS was derived from the validated PCS to similarly measure the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. At each visit, subjects will be asked to complete the OCS.
Measured: Baseline, 1, 3, and 12 months after SGB
Hospital Anxiety and Depression Scale (HADS)
The HADS was developed for screen for anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression. Subjects will be screened for anxiety and depression on their initial visit.
Measured: Baseline, 1, 3, and 12 months after SGB
Pre-Intervention Expectations
A significant number of social media and news stories have discussed anecdotal success of stellate ganglion blocks for COVID-19-induced olfactory dysfunction. As a result, we propose that participants may have a distorted pre-operative expectation that may affect their subjective rating of improvement in olfaction. Therefore, participants will be asked at baseline, "How confident are you that the stellate ganglion block will improve your smell loss or smell distortion?" Possible answer choices: Not at all, Slightly confident, Somewhat confident, Very confident, Extremely confident.
Measured: Baseline
Patient Satisfaction with Treatment
Participants will be asked at the 1-month virtual visit, "Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?" Possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied. Patients will also be asked at the final visit, "Would you recommend this treatment to a family member or close friend who also suffers from chronic smell loss due to COVID-19?" Possible answer choices: 1) Yes, 2) No.
Measured: 1, 3, and 12 months after SGB
Assessment of the Blind
Immediately after the initial injection, participants will be asked, "Which intervention do you think you received?" Answer choices: 1)Lidocaine (active medication) 2) Saline (placebo).
Measured: 1 Month after SGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start15 Feb 2024
- Primary completion24 Dec 2025 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ParosmiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blinded, Placebo-Controlled Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leigh Sowerby, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055270
- Sponsor's protocol ID
- ReDA 13983
- Acronym
- Stella
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hintschich CA, Fischer R, Hummel T, Wenzel JJ, Bohr C, Vielsmeier V. Persisting olfactory dysfunction in post-COVID-19 is associated with gustatory impairment: Results from chemosensitive testing eight months after the acute infection. PLoS One. 2022 Mar 23;17(3):e0265686. doi: 10.1371/journal.pone.0265686. eCollection 2022.
PubMed 35320821Fortunato F, Martinelli D, Iannelli G, Milazzo M, Farina U, Di Matteo G, De Nittis R, Ascatigno L, Cassano M, Lopalco PL, Prato R. Self-reported olfactory and gustatory dysfunctions in COVID-19 patients: a 1-year follow-up study in Foggia district, Italy. BMC Infect Dis. 2022 Jan 22;22(1):77. doi: 10.1186/s12879-022-07052-8.
PubMed 35065619Khan AM, Kallogjeri D, Piccirillo JF. Growing Public Health Concern of COVID-19 Chronic Olfactory Dysfunction. JAMA Otolaryngol Head Neck Surg. 2022 Jan 1;148(1):81-82. doi: 10.1001/jamaoto.2021.3379.
PubMed 34792577Lerner DK, Garvey KL, Arrighi-Allisan AE, Filimonov A, Filip P, Shah J, Tweel B, Del Signore A, Schaberg M, Colley P, Govindaraj S, Iloreta AM. Clinical Features of Parosmia Associated With COVID-19 Infection. Laryngoscope. 2022 Mar;132(3):633-639. doi: 10.1002/lary.29982. Epub 2021 Dec 13.
PubMed 34870334Schambeck SE, Crowell CS, Wagner KI, D'Ippolito E, Burrell T, Mijocevic H, Protzer U, Busch DH, Gerhard M, Poppert H, Beyer H. Phantosmia, Parosmia, and Dysgeusia Are Prolonged and Late-Onset Symptoms of COVID-19. J Clin Med. 2021 Nov 12;10(22):5266. doi: 10.3390/jcm10225266.
PubMed 34830550Hopkins C, Surda P, Vaira LA, Lechien JR, Safarian M, Saussez S, Kumar N. Six month follow-up of self-reported loss of smell during the COVID-19 pandemic. Rhinology. 2021 Feb 1;59(1):26-31. doi: 10.4193/Rhin20.544.
PubMed 33320115Keller A, Malaspina D. Hidden consequences of olfactory dysfunction: a patient report series. BMC Ear Nose Throat Disord. 2013 Jul 23;13(1):8. doi: 10.1186/1472-6815-13-8.
PubMed 23875929Santos DV, Reiter ER, DiNardo LJ, Costanzo RM. Hazardous events associated with impaired olfactory function. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):317-9. doi: 10.1001/archotol.130.3.317.
PubMed 15023839Pang NY, Song HJJMD, Tan BKJ, Tan JX, Chen ASR, See A, Xu S, Charn TC, Teo NWY. Association of Olfactory Impairment With All-Cause Mortality: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):436-445. doi: 10.1001/jamaoto.2022.0263.
PubMed 35389456Addison AB, Wong B, Ahmed T, Macchi A, Konstantinidis I, Huart C, Frasnelli J, Fjaeldstad AW, Ramakrishnan VR, Rombaux P, Whitcroft KL, Holbrook EH, Poletti SC, Hsieh JW, Landis BN, Boardman J, Welge-Lussen A, Maru D, Hummel T, Philpott CM. Clinical Olfactory Working Group consensus statement on the treatment of postinfectious olfactory dysfunction. J Allergy Clin Immunol. 2021 May;147(5):1704-1719. doi: 10.1016/j.jaci.2020.12.641. Epub 2021 Jan 13.
PubMed 33453291
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia: Double-Blinded, Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06055270
- Acronym / sponsor ID
- Stella / ReDA 13983
- Conditions
- Parosmia
- Keywords
- Long-COVID, Olfactory disfunction, smell, olfaction, anosmia, bad smell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis, affecting up to 1.2 million people in the United States. Olfactory dysfunction significantly impacts one's quality of life by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform specific jobs. Olfactory loss is also an independent predictor of anxiety, depression, and mortality.
Recent research suggests that parosmia, more so than hyposmia, can increase anxiety, depression, and even suicidal ideation. While the pandemic has advanced the scientific community's interest in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or "Long COVID" symptoms, have been hypothesized to result from sympathetic nervous system dysfunction. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies before the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted in modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality of life, but it lacked a control group.
Therefore, we propose a double-blinded, placebo-controlled, randomized clinical trial assessing the efficacy of a stellate ganglion block with Lidocaine versus saline injection in up to 50 participants with persistent COVID-19-associated olfactory dysfunction.
Detailed description
This will be a double-blinded, placebo-controlled, randomized clinical to assess the efficacy of Stellate Ganglion Block with Lidocaine 1% (8mL). Participants with parosmia will be randomly assigned to SGB with Lidocaine 1% (8mL) or Placebo (saline solution). Baseline assessment will happen in person and will consist on demographic information, Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR), Clinical Global Impression: Severity Scale (CGI-S), University of Pennsylvania Smell Identification Test (UPSIT), Long-COVID Questionnaire (LCQ), Olfaction Catastrophizing Scale (OCS), Hospital Anxiety and Depression Scale (HADS), Pre-Intervention Expectations. Then, after the assigned interventional procedures are performed three remote visits will be performed as follow-ups (1, 3, and 12 months), in which the variables above will be reassessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blinded, Placebo-Controlled Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboThe placebo sham injection will be performed in an identical fashion as the stellate ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of Lidocaine. |
| Stellate Ganglion Block | Experimental | Procedure: Stellate Ganglion BlockThe ultrasound-guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 to 70
- Diagnosis of COVID-19 at least 6 months prior to study enrollment with self-reported parosmia
- Ability to read, write, and understand English
- Score of at least 15 on DiSODOR
Key exclusion criteria (16 listed)
- History of smell loss or change prior to COVID-19 infection
- History of conditions known to impact olfactory function:
- Currently using concomitant therapies specifically for the treatment of olfactory dysfunction
- Inability to tolerate a needle injection into the neck
- History of coexisting conditions that make SGB contraindicated:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockAlso: SGB, sympathetic blockAll SGBs will be performed by a board-certified anesthesiologist and pain management specialist with extensive experience performing SGBs. The laterality of the SGB will be randomized between the left and right sides of the neck. Participants will be asked to abstain from eating and drinking for 8 hours prior to the SGB. Using ultrasound guidance, the transverse process of the C6 vertebra is identified. Color-doppler is used to identify blood vessels. A 27-gauge needle is used to anesthetize the superficial skin with 1% lidocaine. Then, a 21-gauge ultrasound needle is advanced using an in-plane technique from lateral to medial with careful avoidance of neurovascular structures. After negative aspiration, 8 mL of 1% Lidocaine is deposited beneath the prevertebral fascia and above the Longus coli muscle into the stellate ganglion. | Procedure or surgery | Stellate Ganglion Block |
| PlaceboAlso: Placebo sham injectionThe placebo sham injection will be performed in an identical fashion as the stellate ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of Lidocaine | Other | Placebo Group |
Primary outcome
Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)
Time frame: Baseline, 1, 3, and 12 months after SGB
The DisODOR is a disease-specific questionnaire that assesses for physical problems, functional limitations, and emotional consequences of parosmia secondary to any etiology. The instrument contains 29 total items with each scored on a 5-point Likert scale from 0 to 4. The minimal clinically important difference (MCID) for the instrument is 15.
9 secondary outcomes
Clinical Global Impression - Severity Scale (CGI-S)
Time frame: Baseline
Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: 1, 3, and 12 months after SGB
University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey).
Time frame: Baseline
Long-COVID Questionnaire (LCQ)
Time frame: Baseline, 1, 3, and 12 months after SGB
Olfaction Catastrophizing Scale (OCS)
Time frame: Baseline, 1, 3, and 12 months after SGB
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 1, 3, and 12 months after SGB
Pre-Intervention Expectations
Time frame: Baseline
Patient Satisfaction with Treatment
Time frame: 1, 3, and 12 months after SGB
Assessment of the Blind
Time frame: 1 Month after SGB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Results publication: PubMed 35320821Hintschich CA, Fischer R, Hummel T, Wenzel JJ, Bohr C, Vielsmeier V. Persisting olfactory dysfunction in post-COVID-19 is associated with gustatory impairment: Results from chemosensitive testing eight months after the acute infection. PLoS One. 2022 Mar 23;17(3):e0265686. doi: 10.1371/journal.pone.0265686. eCollection 2022.
- Results publication: PubMed 35065619Fortunato F, Martinelli D, Iannelli G, Milazzo M, Farina U, Di Matteo G, De Nittis R, Ascatigno L, Cassano M, Lopalco PL, Prato R. Self-reported olfactory and gustatory dysfunctions in COVID-19 patients: a 1-year follow-up study in Foggia district, Italy. BMC Infect Dis. 2022 Jan 22;22(1):77. doi: 10.1186/s12879-022-07052-8.
- Results publication: PubMed 34792577Khan AM, Kallogjeri D, Piccirillo JF. Growing Public Health Concern of COVID-19 Chronic Olfactory Dysfunction. JAMA Otolaryngol Head Neck Surg. 2022 Jan 1;148(1):81-82. doi: 10.1001/jamaoto.2021.3379.
- Results publication: PubMed 34870334Lerner DK, Garvey KL, Arrighi-Allisan AE, Filimonov A, Filip P, Shah J, Tweel B, Del Signore A, Schaberg M, Colley P, Govindaraj S, Iloreta AM. Clinical Features of Parosmia Associated With COVID-19 Infection. Laryngoscope. 2022 Mar;132(3):633-639. doi: 10.1002/lary.29982. Epub 2021 Dec 13.
- Results publication: PubMed 34830550Schambeck SE, Crowell CS, Wagner KI, D'Ippolito E, Burrell T, Mijocevic H, Protzer U, Busch DH, Gerhard M, Poppert H, Beyer H. Phantosmia, Parosmia, and Dysgeusia Are Prolonged and Late-Onset Symptoms of COVID-19. J Clin Med. 2021 Nov 12;10(22):5266. doi: 10.3390/jcm10225266.
- Results publication: PubMed 33320115Hopkins C, Surda P, Vaira LA, Lechien JR, Safarian M, Saussez S, Kumar N. Six month follow-up of self-reported loss of smell during the COVID-19 pandemic. Rhinology. 2021 Feb 1;59(1):26-31. doi: 10.4193/Rhin20.544.
- Results publication: PubMed 23875929Keller A, Malaspina D. Hidden consequences of olfactory dysfunction: a patient report series. BMC Ear Nose Throat Disord. 2013 Jul 23;13(1):8. doi: 10.1186/1472-6815-13-8.
- Results publication: PubMed 15023839Santos DV, Reiter ER, DiNardo LJ, Costanzo RM. Hazardous events associated with impaired olfactory function. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):317-9. doi: 10.1001/archotol.130.3.317.
- Results publication: PubMed 35389456Pang NY, Song HJJMD, Tan BKJ, Tan JX, Chen ASR, See A, Xu S, Charn TC, Teo NWY. Association of Olfactory Impairment With All-Cause Mortality: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):436-445. doi: 10.1001/jamaoto.2022.0263.
- Results publication: PubMed 33453291Addison AB, Wong B, Ahmed T, Macchi A, Konstantinidis I, Huart C, Frasnelli J, Fjaeldstad AW, Ramakrishnan VR, Rombaux P, Whitcroft KL, Holbrook EH, Poletti SC, Hsieh JW, Landis BN, Boardman J, Welge-Lussen A, Maru D, Hummel T, Philpott CM. Clinical Olfactory Working Group consensus statement on the treatment of postinfectious olfactory dysfunction. J Allergy Clin Immunol. 2021 May;147(5):1704-1719. doi: 10.1016/j.jaci.2020.12.641. Epub 2021 Jan 13.
- Individual participant dataSharing planned: No
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RecruitingPhase 2/3
Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
Smell Dysfunction, Olfactory Disorder
Recruiting
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Paraosmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Dihel, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stellate Ganglion Block in people with Parosmia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lanette Friesen-Waldner, Ph.D (5196466100 ext. 61125, lanette.friesen-waldner@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR) (time frame: Baseline, 1, 3, and 12 months after SGB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055270, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.