Olfaction DisordersSENSONCT06589375
Study of EEG and Nasal Stimulus in Olfactory Disorders
A study testing Sniffin'Sticks in people with Olfaction Disorders, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Neuroscent aims to analyze EEG signals induced by olfactory stimuli in individuals with normal and impaired olfactory functions, with a focus on patients with tinnitus. The study seeks to develop reliable diagnostic methods using EEG to differentiate between normosmic and hyposmic subjects during olfactory tests… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olfaction Disorders
- What is being tested?
- Sniffin'Sticks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2024to 31 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects over 18 years of age who have given consent for the collection of specified data, including medical history and personal information, for the purposes of project implementation and in accordance with the ethical standards of the institutions where the project will be conducted.
Who cannot join
- Previous fractures of the facial bones, particularly the ethmoid bone.
- Active tumors of the brain or face, including tumors of the nose, paranasal sinuses, oral cavity, or nasopharynx.
- Active nasal-sinus conditions, particularly radiologically proven sinusitis.
- Mass in the pontocerebellar angle, especially schwannoma of the VIII nerve.
- Patients with acute and chronic inflammatory diseases of the middle ear, otosclerosis, inner ear diseases (especially Meniere's disease), objective tinnitus, and tinnitus caused by middle ear pathologies and CPA tumors.
- Neurodegenerative diseases (especially Alzheimer's and Parkinson's disease).
Show all 9Show fewer
- Known history of neuropsychiatric or cerebral disorders.
- Use of psychotropic drugs or drugs active on the central nervous system.
- Alcohol and drug abuse.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neuroscent: EEG Analysis of Cortical Signals Induced by Olfactory Stimuli in Normosmic Subjects and Individuals With Olfactory Disorders, With an In-depth Study of Olfactory Pathways in Patients With Tinnitus
Neuroscent aims to analyze EEG signals induced by olfactory stimuli in individuals with normal and impaired olfactory functions, with a focus on patients with tinnitus. The study seeks to develop reliable diagnostic methods using EEG to differentiate between normosmic and hyposmic subjects during olfactory tests, potentially enhancing our understanding of the brain's response to olfactory stimuli. This 24-month interventional study with a device to be patented will involve 1000 participants and aims to establish more effective diagnostic and therapeutic tools for olfactory disorders
Read the detailed description
The Neuroscent project investigates the EEG signals elicited by olfactory stimuli in both normosmic individuals and those with olfactory disorders, with a focus on tinnitus patients. The primary objective is to utilize EEG analysis to identify and quantify brain wave responses during olfactory tests with Sniffin' Sticks, aiming to accurately differentiate between normosmic and hyposmic subjects. This research aims to enhance the diagnostic precision and understanding of the interplay between olfactory and auditory stimuli in the brain. The 24-month, interventional study with a device to be patented, co-financed by the Ministry of Health and Ministry of the Interior under the PNRR 2023, will recruit 1000 participants divided into four groups: normosmics (550), hyposmics (150), tinnitus patients with hyposmia (150), and tinnitus patients without hyposmia (150). Participants will undergo comprehensive olfactory assessments, including the Sniffin' Sticks test, and EEG recordings will be taken during olfactory stimulation to capture brain wave patterns. Advanced data analysis techniques, such as Random Forest algorithms and t-SNE dimensionality reduction, will be employed to classify and interpret the EEG signals, aiming to develop effective diagnostic and therapeutic tools for olfactory disorders, thereby improving clinical outcomes and quality of life for affected individuals.
- Conditions
- Olfaction Disorders
- Being tested
- Sniffin'Sticks
- Keywords
- Olfactory stimuli, EEG, Tinnitus, Olfactory disorders, Smell impairment, Olfactometry, Brain waves
- Medical subject headings
- Olfaction Disorders, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffin'SticksDiagnostic test
Also called EEG
The Sniffin' Sticks test, a validated method to evaluate olfactory functions, utilizes pen-like devices to dispense scents for testing identification, discrimination, and detection of odors. In this study, participants' responses to various scents are recorded. EEG (Electroencephalography) captures electrical activity in the brain during exposure to these odors by using an EEG cap fitted with electrodes on the scalp. This allows for the monitoring of brain wave patterns in response to olfactory stimuli. Both the Sniffin' Sticks test and EEG recordings are conducted simultaneously, providing a dual assessment of behavioral reactions and brain activity to odors. The goal of the study is to compare brain wave patterns and olfactory function in normosmic (normal smell), hyposmic (reduced smell), and tinnitus patients with and without olfactory impairments, delivering comprehensive insights into the neural basis of olfactory perception.
| Study group | Role | What they receive |
|---|---|---|
| Normosmic | Active comparator | Participants in this group have normal olfactory function, as determined by the Sniffin' Sticks test. They will undergo EEG analysis while being exposed to various olfactory stimuli to establish baseline brain wave patterns for normal olfactory responses.
(n=550) Receives: Diagnostic Test: Sniffin'Sticks |
| Hyposmic | Active comparator | Participants in this group have impaired olfactory function (hyposmia), confirmed through the Sniffin' Sticks test. They will undergo EEG analysis during olfactory stimulation to identify differences in brain wave patterns compared to normosmic individuals. (n=150) Receives: Diagnostic Test: Sniffin'Sticks |
| Tinnitus Patients with Hyposmia | Active comparator | This group includes participants who have both tinnitus and hyposmia. They will be subjected to EEG analysis during olfactory testing to investigate the interaction between olfactory and auditory disorders and how these conditions may influence brain wave responses. (n=150) Receives: Diagnostic Test: Sniffin'Sticks |
| Tinnitus Patients without Hyposmia | Active comparator | Participants in this group have tinnitus but normal olfactory function. They will undergo the same EEG and olfactory tests to explore the impact of tinnitus on brain wave patterns in the absence of olfactory disorders and to compare their responses with those of other groups. (n=150) Receives: Diagnostic Test: Sniffin'Sticks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and data collection
During this period, 1000 participants > 18 y/o will be recruited and divided into four distinct groups: normosmics (550), hyposmics (150), tinnitus patients with hyposmia (150), and tinnitus patients without hyposmia (150). The primary outcome of the Neuroscent project is to assess the ability of EEG analysis to distinguish between normosmic and hyposmic participants during olfactory stimulation using the Sniffin' Sticks test.
Measured: 22 months
EEG Parameters (in µV²)
Alpha Power: Measured in microvolts squared (µV²), representing the magnitude of Alpha wave activity during olfactory stimulation. Theta Power: Measured in microvolts squared (µV²), representing the magnitude of Theta wave activity during olfactory stimulation. We will make use of the Fourier transform as well, which is inherently dimensionless. The data acquisition setup involves placing blindfolded participants in an isolated room and administering three randomized olfactory stimuli (pure olfactory, trigeminal, and olfactory-gustatory) while collecting EEG data. Sessions start and end with a 30-second resting state.
Measured: 22 months
Behavioral/Performance Measures (Scores)
Olfactory Threshold Scores (as per routinary diagnosis of olfactory performances): Derived from the Sniffin' Sticks test, these scores quantify participants' ability to detect odors, classifying them as normosmic or hyposmic. All the participants will undergo a complete olfactory assessment through the Sniffin' Sticks test. These are represented as numerical scores. The maximum score obtainable in the full Sniffin' Sticks test, which includes the three sub-tests (Threshold, Discrimination, Identification - TDI), is 48. This maximum score is achieved by summing the highest possible score from each of the three components: 16 for olfactory threshold (Threshold), 16 for olfactory discrimination (Discrimination), and 16 for olfactory identification (Identification).
Measured: 22 months
Model Performance Metrics (Accuracy)
Random Forest Model Classification Accuracy: The accuracy of the classification model used to distinguish between normosmic and hyposmic participants based on EEG data, usually expressed as a percentage or a value between 0 and 1.
Measured: 22 months
Dimensionality Change Outputs (t-SNE)
t-SNE Features: Although these don't have a specific unit, they represent the reduced dimensional data points used as features in the Random Forest model. These are typically dimensionless and used in the context of visualizing and improving model performance.
Measured: 22 months
Secondary outcomes (7)
Pure Tone Audiometry Test
Pure Tone Audiometry (PTA), as per routinary diagnosis of Tinnitus: Measures hearing thresholds across frequencies, reported in decibels Hearing Level (dB HL) to determine the degree of hearing loss. The results are plotted on an audiogram, which shows the person's hearing threshold at different frequencies; a normal audiogram threshold is 0-20 dB HL between 250 and 8k Hz.
Measured: 22 months (Simultaneously with the primary outcome)
Behavioral/Performance Measures (Scores)
Tinnitus Handicap Inventory (THI): Scores the impact of tinnitus on a scale from 0 to 100, where a higher score indicates a worse impact of tinnitus.
Measured: 22 months (Simultaneously with the primary outcome)
EEG Parameters
EEG Data: Analyzed during exposure to olfactory stimuli (as per Primary Outcome), with features reduced via t-SNE and classified using a Random Forest algorithm.
Measured: 22 months (Simultaneously with the primary outcome)
Model Performance Metrics
Random Forest Model Classification Accuracy: Measures the accuracy of the model used to classify participants across the four groups. This is typically expressed as a percentage or a value between 0 and 1. Fleiss' Kappa Statistic: Used to evaluate the agreement of classification, reported as a kappa coefficient.
Measured: 22 months (Simultaneously with the primary outcome)
Power Analysis and Post-hoc Analyses
Power Analysis: Ensures the sample size is adequate to detect significant effects. This is typically expressed in terms of statistical power (e.g., 0.8 or 80%). Post-hoc Analyses: Conducted if significant differences are found, usually involving p-values or effect sizes.
Measured: 22 months (Simultaneously with the primary outcome)
Auditory Brainstem Response (ABR)
Auditory Brainstem Response (ABR) as per routinary diagnosis of Tinnitus: Assesses the auditory nerve and brainstem's response to sound stimuli by measuring electrical activity in the brain. Results are typically presented as waveforms, with particular focus on latency and amplitude of specific waves, measured in milliseconds (ms) and microvolts (µV) respectively, to evaluate neural pathways involved in hearing.
Measured: 22 months (Simultaneously with the primary outcome)
Tympanometry
Tympanometry, as per routinary diagnosis of Tinnitus: Evaluates middle ear function by measuring tympanic membrane mobility, with results reported in decapascals (daPa) and milliliters (mL). The pressure reading in tympanometry reflects the air pressure in the middle ear cavity. A normal tympanogram shows peak compliance when the pressure in the ear canal matches the pressure in the middle ear, indicating normal middle ear function. The two units of measurement, pressure and compliance, are plotted on a two-dimensional graph. Pressure (daPa) is plotted on the x-axis and compliance, measured in mL, is plotted on the y-axis in the two-dimensional graph
Measured: 22 months (Simultaneously with the primary outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study involves multiple groups of participants who will undergo EEG analysis during olfactory stimulation to assess brain wave responses. The groups include normosmics, hyposmics, tinnitus patients with hyposmia, and tinnitus patients without hyposmia. The study aims to differentiate between these groups and investigate the relationship between olfactory disorders and also highlight the olfactory features of patients with tinnitus. Each group will receive the same olfactory tests and EEG recordings, but they will be compared against each other to understand the different responses and interactions.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Cesare Passali, Prof, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589375
- Sponsor's protocol ID
- ID6911
- Acronym
- SENSO
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscent: EEG Analysis of Cortical Signals Induced by Olfactory Stimuli in Normosmic Subjects and Individuals With Olfactory Disorders, With an In-depth Study of Olfactory Pathways in Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT06589375
- Acronym / sponsor ID
- SENSO / ID6911
- Conditions
- Olfaction Disorders
- Keywords
- Olfactory stimuli, EEG, Tinnitus, Olfactory disorders, Smell impairment, Olfactometry, Brain waves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Neuroscent aims to analyze EEG signals induced by olfactory stimuli in individuals with normal and impaired olfactory functions, with a focus on patients with tinnitus. The study seeks to develop reliable diagnostic methods using EEG to differentiate between normosmic and hyposmic subjects during olfactory tests, potentially enhancing our understanding of the brain's response to olfactory stimuli. This 24-month interventional study with a device to be patented will involve 1000 participants and aims to establish more effective diagnostic and therapeutic tools for olfactory disorders
Detailed description
The Neuroscent project investigates the EEG signals elicited by olfactory stimuli in both normosmic individuals and those with olfactory disorders, with a focus on tinnitus patients. The primary objective is to utilize EEG analysis to identify and quantify brain wave responses during olfactory tests with Sniffin' Sticks, aiming to accurately differentiate between normosmic and hyposmic subjects. This research aims to enhance the diagnostic precision and understanding of the interplay between olfactory and auditory stimuli in the brain. The 24-month, interventional study with a device to be patented, co-financed by the Ministry of Health and Ministry of the Interior under the PNRR 2023, will recruit 1000 participants divided into four groups: normosmics (550), hyposmics (150), tinnitus patients with hyposmia (150), and tinnitus patients without hyposmia (150). Participants will undergo comprehensive olfactory assessments, including the Sniffin' Sticks test, and EEG recordings will be taken during olfactory stimulation to capture brain wave patterns. Advanced data analysis techniques, such as Random Forest algorithms and t-SNE dimensionality reduction, will be employed to classify and interpret the EEG signals, aiming to develop effective diagnostic and therapeutic tools for olfactory disorders, thereby improving clinical outcomes and quality of life for affected individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study involves multiple groups of participants who will undergo EEG analysis during olfactory stimulation to assess brain wave responses. The groups include normosmics, hyposmics, tinnitus patients with hyposmia, and tinnitus patients without hyposmia. The study aims to differentiate between these groups and investigate the relationship between olfactory disorders and also highlight the olfactory features of patients with tinnitus. Each group will receive the same olfactory tests and EEG recordings, but they will be compared against each other to understand the different responses and interactions.
| Arm | Type | Receives |
|---|---|---|
| Normosmic | Active comparator | Diagnostic Test: Sniffin'SticksParticipants in this group have normal olfactory function, as determined by the Sniffin' Sticks test. They will undergo EEG analysis while being exposed to various olfactory stimuli to establish baseline brain wave patterns for normal olfactory responses. (n=550) |
| Hyposmic | Active comparator | Diagnostic Test: Sniffin'SticksParticipants in this group have impaired olfactory function (hyposmia), confirmed through the Sniffin' Sticks test. They will undergo EEG analysis during olfactory stimulation to identify differences in brain wave patterns compared to normosmic individuals. (n=150) |
| Tinnitus Patients with Hyposmia | Active comparator | Diagnostic Test: Sniffin'SticksThis group includes participants who have both tinnitus and hyposmia. They will be subjected to EEG analysis during olfactory testing to investigate the interaction between olfactory and auditory disorders and how these conditions may influence brain wave responses. (n=150) |
| Tinnitus Patients without Hyposmia | Active comparator | Diagnostic Test: Sniffin'SticksParticipants in this group have tinnitus but normal olfactory function. They will undergo the same EEG and olfactory tests to explore the impact of tinnitus on brain wave patterns in the absence of olfactory disorders and to compare their responses with those of other groups. (n=150) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects over 18 years of age who have given consent for the collection of specified data, including medical history and personal information, for the purposes of project implementation and in accordance with the ethical standards of the institutions where the project will be conducted.
Key exclusion criteria (9 listed)
- Previous fractures of the facial bones, particularly the ethmoid bone.
- Active tumors of the brain or face, including tumors of the nose, paranasal sinuses, oral cavity, or nasopharynx.
- Active nasal-sinus conditions, particularly radiologically proven sinusitis.
- Mass in the pontocerebellar angle, especially schwannoma of the VIII nerve.
- Patients with acute and chronic inflammatory diseases of the middle ear, otosclerosis, inner ear diseases (especially Meniere's disease), objective tinnitus, and tinnitus caused by middle ear pathologies and CPA tumors.
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 |
|---|---|---|
| Sniffin'SticksAlso: EEGThe Sniffin' Sticks test, a validated method to evaluate olfactory functions, utilizes pen-like devices to dispense scents for testing identification, discrimination, and detection of odors. In this study, participants' responses to various scents are recorded. EEG (Electroencephalography) captures electrical activity in the brain during exposure to these odors by using an EEG cap fitted with electrodes on the scalp. This allows for the monitoring of brain wave patterns in response to olfactory stimuli. Both the Sniffin' Sticks test and EEG recordings are conducted simultaneously, providing a dual assessment of behavioral reactions and brain activity to odors. The goal of the study is to compare brain wave patterns and olfactory function in normosmic (normal smell), hyposmic (reduced smell), and tinnitus patients with and without olfactory impairments, delivering comprehensive insights into the neural basis of olfactory perception. | Diagnostic test | Hyposmic, Normosmic, Tinnitus Patients with Hyposmia, Tinnitus Patients without Hyposmia |
Primary outcome
Enrollment and data collection
Time frame: 22 months
During this period, 1000 participants > 18 y/o will be recruited and divided into four distinct groups: normosmics (550), hyposmics (150), tinnitus patients with hyposmia (150), and tinnitus patients without hyposmia (150). The primary outcome of the Neuroscent project is to assess the ability of EEG analysis to distinguish between normosmic and hyposmic participants during olfactory stimulation using the Sniffin' Sticks test.
EEG Parameters (in µV²)
Time frame: 22 months
Alpha Power: Measured in microvolts squared (µV²), representing the magnitude of Alpha wave activity during olfactory stimulation. Theta Power: Measured in microvolts squared (µV²), representing the magnitude of Theta wave activity during olfactory stimulation. We will make use of the Fourier transform as well, which is inherently dimensionless. The data acquisition setup involves placing blindfolded participants in an isolated room and administering three randomized olfactory stimuli (pure olfactory, trigeminal, and olfactory-gustatory) while collecting EEG data. Sessions start and end with a 30-second resting state.
Behavioral/Performance Measures (Scores)
Time frame: 22 months
Olfactory Threshold Scores (as per routinary diagnosis of olfactory performances): Derived from the Sniffin' Sticks test, these scores quantify participants' ability to detect odors, classifying them as normosmic or hyposmic. All the participants will undergo a complete olfactory assessment through the Sniffin' Sticks test. These are represented as numerical scores. The maximum score obtainable in the full Sniffin' Sticks test, which includes the three sub-tests (Threshold, Discrimination, Identification - TDI), is 48. This maximum score is achieved by summing the highest possible score from each of the three components: 16 for olfactory threshold (Threshold), 16 for olfactory discrimination (Discrimination), and 16 for olfactory identification (Identification).
Model Performance Metrics (Accuracy)
Time frame: 22 months
Random Forest Model Classification Accuracy: The accuracy of the classification model used to distinguish between normosmic and hyposmic participants based on EEG data, usually expressed as a percentage or a value between 0 and 1.
Dimensionality Change Outputs (t-SNE)
Time frame: 22 months
t-SNE Features: Although these don't have a specific unit, they represent the reduced dimensional data points used as features in the Random Forest model. These are typically dimensionless and used in the context of visualizing and improving model performance.
7 secondary outcomes
Pure Tone Audiometry Test
Time frame: 22 months (Simultaneously with the primary outcome)
Behavioral/Performance Measures (Scores)
Time frame: 22 months (Simultaneously with the primary outcome)
EEG Parameters
Time frame: 22 months (Simultaneously with the primary outcome)
Model Performance Metrics
Time frame: 22 months (Simultaneously with the primary outcome)
Power Analysis and Post-hoc Analyses
Time frame: 22 months (Simultaneously with the primary outcome)
Auditory Brainstem Response (ABR)
Time frame: 22 months (Simultaneously with the primary outcome)
Tympanometry
Time frame: 22 months (Simultaneously with the primary outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Giulio Cesare Passali, Prof study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Sniffin'Sticks in people with Olfaction Disorders, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 1 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Giuseppe Maulucci, Prof (+390630154265, giuseppe.maulucci@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment and data collection (time frame: 22 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.