Smell DysfunctionPhase 2/3NCT05855369
Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
A Phase 2/3 study testing Trigeminal Nerve Stimulation (TNS) and Active Smell Training (ST) in people with Smell Dysfunction and Olfactory Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smell Dysfunction, Olfactory Disorder, Long COVID
- What is being tested?
- Trigeminal Nerve Stimulation (TNS) and Active Smell Training (ST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 31 May 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
- at least 1-month from SARS-coV-2 PCR-positive and/or rapid home-positive tests
- normal sense of smell prior to COVID
- naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
- able to comprehend English and provide informed consent
Who cannot join
- history of head injury (e.g. sport, accident, combat blast)
- sinonasal condition (e.g. upper respiratory infection, rhinosinusitis, polyps)
- neurological disorder (e.g. epilepsy, neurodegenerative disorder, narcolepsy)
- serious mental illness (e.g. schizophrenia, bipolar, or other psychotic disorder)
- suicidal ideation within the last month
- current (≤6 months) heavy cigarette smoker (heavy defined as ≥ 10 pack-years)
Show all 9Show fewer
- oral/nasal steroids or other intranasal medications within the last month
- immunomodulatory medications
- pregnant or trying to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Bernadette Cortese, PhD, 843-792-6922, corteseb@musc.edu
About this study
Official title: A Randomized Controlled Trial of Smell Training and Trigeminal Nerve Stimulation in the Treatment of COVID-related Persistent Smell Loss
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.
Read the detailed description
Sudden smell loss (SL), a hallmark feature of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-coV-2/COVID), frequently persists well past the initial recovery; rates of unresolved anosmia (total loss) are 21%, with unresolved hyposmia (reduced smell) or parosmia (distorted smell) higher at nearly 50%. SL is now recognized as a core symptom of "long COVID" (LC), which also includes other impairments in mood, cognition, and sleep. Given that SL itself can negatively impact many of the same problems being recognized in the symptomatology of LC, it is likely that SL is both a symptom of LC and a contributing factor that worsens other LC symptoms (i.e. mood, cognition, sleep, etc.). As such, successful treatment of SL could also help to improve these other LC symptoms.
Smell/olfactory training (ST) is currently being studied as a treatment for COVID-related SL. Classic ST requires twice daily practice of sniffing odorants over the course of 3 months to regenerate olfactory neurons, engage smell-related cognitive functions, and retrain the brain to smell. ST is promising as a stand-alone treatment. However, its limitations include the burden of many months of daily practice that often leads to sub-optimal compliance and dropout.
The current study aims to determine whether the benefits of ST can be accelerated and enhanced by using a novel, adjunct neuromodulatory intervention to conventional ST. Trigeminal nerve stimulation (TNS) is a non-invasive, pain-free, method of neuromodulation that delivers low levels of electrical stimulation to the trigeminal circuit, having potential to enhance smell function through activation of the highly connected olfactory-intranasal trigeminal systems. Prior work demonstrated TNS-enhanced psychophysical detection of odorants. Yet the effects of TNS are extensive, i.e. improved executive functioning (e.g. attention), sleep quality, and daytime sleepiness, as well as therapeutic efficacy across a number of neuropsychiatric disorders. Thus, TNS-as an adjunct to ST-may not only improve overall efficacy and speed of recovery of SL, but may help to treat some of the other symptoms of LC that ST, and improvement in smell function, may not fully resolve.
This randomized, controlled trial (RCT) of ST and combination TNS and ST in adults with COVID-related SL will use a 3- group design: Group 1) Active ST (N=60), Group 2) Placebo ST (PBO, N=60), and Group 3) Active TNS plus Active ST (N=60). Our primary objectives are to 1) determine the efficacy of ST versus potential natural gains in function, 2) determine the TNS-enhanced effects of ST on SL, and 3) determine whether TNS+ST is more efficacious than ST in treating the other symptoms of LC.
- Conditions
- Smell Dysfunction, Olfactory Disorder, Long COVID
- Being tested
- Trigeminal Nerve Stimulation (TNS), Active Smell Training (ST), Placebo Smell Training (PBO)
- Keywords
- COVID-19, Parosmia, Hyposmia, Anosmia, Phantosmia, Dysosmia, Olfactory Training, Neuromodulation, Non-invasive Brain Stimulation
- Medical subject headings
- Olfaction Disorders, Post-Acute COVID-19 Syndrome, COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal Nerve Stimulation (TNS)Device
Also called Transcutaneous Electrical Nerve Stimulation
Non-invasive, pain-free, low-level electrical stimulation to the forehead to modulate the trigeminal nerve and enhance smell function through activation of the highly connected olfactory-intranasal trigeminal brain circuits.
Active Smell Training (ST)Other
Also called Olfactory Training
Sniffing various higher intensity odorant chemicals while performing odor-related cognitive tasks. 16 odorant chemicals will be used for training including: 2 phenyl ethanol, eugenol, lemon, eucalyptus, cinnamon, peppermint, coffee, mandarin, lavender, vanilla, lilac, ginger, chocolate, thyme, banana, and bacon.
Placebo Smell Training (PBO)Other
Sniffing the same lower intensity odorant chemicals (i.e. N-butanol and 2-phenyl ethanol) over the course of the trial and performing no odor-related cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST) | Active comparator | 30 minutes of once/day TNS and twice/day ST conducted 5 days/week for 12 weeks and a total of 60 stimulation and 120 smell training sessions Receives: Device: Trigeminal Nerve Stimulation (TNS); Other: Active Smell Training (ST) |
| Active Smell Training (ST) | Active comparator | 5 minutes of daily ST conducted twice/day, 5 days/week for 12 weeks and a total of 120 training session Receives: Other: Active Smell Training (ST) |
| Placebo Smell Training (PBO) | Placebo comparator | 5 minutes of daily PBO conducted twice/day, 5 days/week for 12 weeks and a total of 120 training sessions Receives: Other: Placebo Smell Training (PBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks
Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.
Measured: 2 times: 4 weeks, 12 weeks
Change in Perceived Intensity of Odorants from Baseline to 4 and 12 Weeks
Perceived intensity on 100-mm visual analog scales with anchor points: 0="imperceptible" to 100="extremely intense" will be rated for suprathreshold concentrations of PEA, vanilla, eugenol, and eucalyptus.
Measured: 2 times: 4 weeks, 12 weeks
Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks
Perceived hedonics on 100-mm visual analog scales with anchor points: 0="extremely unpleasant" to 100="extremely pleasant".
Measured: 2 times: 4 weeks, 12 weeks
Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks
The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.
Measured: 2 times: 4 weeks, 12 weeks
Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks
The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).
Measured: 2 times: 4 weeks, 12 weeks
Secondary outcomes (8)
Change in Long COVID Symptoms from Baseline to 4 and 12 Weeks
53 long COVID symptoms (scored from 0-53 reflecting the number of different symptoms experienced) and the impact of those symptoms (scored from 0=no impact to 10=maximal impact) will be obtained.
Measured: 2 times: 4 weeks, 12 weeks
Change in Sustained Attention from Baseline to 4 and 12 Weeks
The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9).
Measured: 2 times: 4 weeks, 12 weeks
Change in Cognitive Function from Baseline to 4 and 12 Weeks
The NIH Toolbox Cognitive Battery is a widely used assessment for detecting cognitive impairment. This test assesses short-term memory, executable performance, attention, and focus.
Measured: 2 times: 4 weeks, 12 weeks
Change in Mood State from Baseline to 4 and 12 Weeks
The Profile of Mood States Short Form (POMS-SF) is a psychological rating scale used to assess transient, distinct mood states across six different dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, and Confusion or Bewilderment.
Measured: 2 times: 4 weeks, 12 weeks
Change in Sleep Quality from Baseline to 4 and 12 Weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Scores greater than 5 are indicative of a sleep disturbance.
Measured: 2 times: 4 weeks, 12 weeks
Change in Excessive Daytime Sleepiness from Baseline to 4 and 12 Weeks
The Epworth Sleepiness Scale (ESS) is a measure intended to assess daytime sleepiness. Items consist of 8 different activities which are rated according to how likely it would be to doze off or fall asleep if engaged in that activity. A score of 10 or more is indicative excessive daytime sleepiness.
Measured: 2 times: 4 weeks, 12 weeks
Change in Symptoms of Depression from Baseline to 4 and 12 Weeks
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item questionnaire to screen for the presence and severity of depression. Items are rated on a 3pt scale ranging from 0="Not at all" to 3="Nearly every day". Total score ranges from 0-27 and is used to classify depression severity: 0-4=None/Minimal; 5-9=Mild; 10-14=Moderate; 15-19=Moderately Severe; 20-27=Severe.
Measured: 2 times: 4 weeks, 12 weeks
Change in Symptoms of Anxiety from Baseline to 4 and 12 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire to screen for presence and severity of anxiety disorder. Items are rated on a 3pt scale ranging from 0="Not at all" to 3="Nearly every day". Total score ranges from 0 to 21 and is used to classify anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).
Measured: 2 times: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start2 Oct 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smell DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Bernadette Cortese, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855369
- Sponsor's protocol ID
- Pro00127790
- Other IDs
- R01DC021179
- Status last verified
- Apr 2026
- First submitted
- 8 May 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Original data (de-identified) will be available to other researchers upon request. Human subjects' rights to privacy will be protected and the identity of human subjects will not be revealed with any request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Smell Training and Trigeminal Nerve Stimulation in the Treatment of COVID-related Persistent Smell Loss
- ClinicalTrials.gov ID
- NCT05855369
- Acronym / sponsor ID
- Pro00127790
- Conditions
- Smell Dysfunction, Olfactory Disorder, Long COVID
- Keywords
- COVID-19, Parosmia, Hyposmia, Anosmia, Phantosmia, Dysosmia, Olfactory Training, Neuromodulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 11 May 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.
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.
Detailed description
Sudden smell loss (SL), a hallmark feature of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-coV-2/COVID), frequently persists well past the initial recovery; rates of unresolved anosmia (total loss) are 21%, with unresolved hyposmia (reduced smell) or parosmia (distorted smell) higher at nearly 50%. SL is now recognized as a core symptom of "long COVID" (LC), which also includes other impairments in mood, cognition, and sleep. Given that SL itself can negatively impact many of the same problems being recognized in the symptomatology of LC, it is likely that SL is both a symptom of LC and a contributing factor that worsens other LC symptoms (i.e. mood, cognition, sleep, etc.). As such, successful treatment of SL could also help to improve these other LC symptoms.
Smell/olfactory training (ST) is currently being studied as a treatment for COVID-related SL. Classic ST requires twice daily practice of sniffing odorants over the course of 3 months to regenerate olfactory neurons, engage smell-related cognitive functions, and retrain the brain to smell. ST is promising as a stand-alone treatment. However, its limitations include the burden of many months of daily practice that often leads to sub-optimal compliance and dropout.
The current study aims to determine whether the benefits of ST can be accelerated and enhanced by using a novel, adjunct neuromodulatory intervention to conventional ST. Trigeminal nerve stimulation (TNS) is a non-invasive, pain-free, method of neuromodulation that delivers low levels of electrical stimulation to the trigeminal circuit, having potential to enhance smell function through activation of the highly connected olfactory-intranasal trigeminal systems. Prior work demonstrated TNS-enhanced psychophysical detection of odorants. Yet the effects of TNS are extensive, i.e. improved executive functioning (e.g. attention), sleep quality, and daytime sleepiness, as well as therapeutic efficacy across a number of neuropsychiatric disorders. Thus, TNS-as an adjunct to ST-may not only improve overall efficacy and speed of recovery of SL, but may help to treat some of the other symptoms of LC that ST, and improvement in smell function, may not fully resolve.
This randomized, controlled trial (RCT) of ST and combination TNS and ST in adults with COVID-related SL will use a 3- group design: Group 1) Active ST (N=60), Group 2) Placebo ST (PBO, N=60), and Group 3) Active TNS plus Active ST (N=60). Our primary objectives are to 1) determine the efficacy of ST versus potential natural gains in function, 2) determine the TNS-enhanced effects of ST on SL, and 3) determine whether TNS+ST is more efficacious than ST in treating the other symptoms of LC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST) | Active comparator | Device: Trigeminal Nerve Stimulation (TNS), Other: Active Smell Training (ST)30 minutes of once/day TNS and twice/day ST conducted 5 days/week for 12 weeks and a total of 60 stimulation and 120 smell training sessions |
| Active Smell Training (ST) | Active comparator | Other: Active Smell Training (ST)5 minutes of daily ST conducted twice/day, 5 days/week for 12 weeks and a total of 120 training session |
| Placebo Smell Training (PBO) | Placebo comparator | Other: Placebo Smell Training (PBO)5 minutes of daily PBO conducted twice/day, 5 days/week for 12 weeks and a total of 120 training sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
- at least 1-month from SARS-coV-2 PCR-positive and/or rapid home-positive tests
- normal sense of smell prior to COVID
- naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
- able to comprehend English and provide informed consent
Key exclusion criteria (9 listed)
- history of head injury (e.g. sport, accident, combat blast)
- sinonasal condition (e.g. upper respiratory infection, rhinosinusitis, polyps)
- neurological disorder (e.g. epilepsy, neurodegenerative disorder, narcolepsy)
- serious mental illness (e.g. schizophrenia, bipolar, or other psychotic disorder)
- suicidal ideation within the last month
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 |
|---|---|---|
| Trigeminal Nerve Stimulation (TNS)Also: Transcutaneous Electrical Nerve StimulationNon-invasive, pain-free, low-level electrical stimulation to the forehead to modulate the trigeminal nerve and enhance smell function through activation of the highly connected olfactory-intranasal trigeminal brain circuits. | Device | Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST) |
| Active Smell Training (ST)Also: Olfactory TrainingSniffing various higher intensity odorant chemicals while performing odor-related cognitive tasks. 16 odorant chemicals will be used for training including: 2 phenyl ethanol, eugenol, lemon, eucalyptus, cinnamon, peppermint, coffee, mandarin, lavender, vanilla, lilac, ginger, chocolate, thyme, banana, and bacon. | Other | Active Smell Training (ST), Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST) |
| Placebo Smell Training (PBO)Sniffing the same lower intensity odorant chemicals (i.e. N-butanol and 2-phenyl ethanol) over the course of the trial and performing no odor-related cognitive tasks. | Other | Placebo Smell Training (PBO) |
Primary outcome
Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.
Change in Perceived Intensity of Odorants from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Perceived intensity on 100-mm visual analog scales with anchor points: 0="imperceptible" to 100="extremely intense" will be rated for suprathreshold concentrations of PEA, vanilla, eugenol, and eucalyptus.
Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Perceived hedonics on 100-mm visual analog scales with anchor points: 0="extremely unpleasant" to 100="extremely pleasant".
Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.
Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).
8 secondary outcomes
Change in Long COVID Symptoms from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Sustained Attention from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Cognitive Function from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Mood State from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Sleep Quality from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Excessive Daytime Sleepiness from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Symptoms of Depression from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Change in Symptoms of Anxiety from Baseline to 4 and 12 Weeks
Time frame: 2 times: 4 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Original data (de-identified) will be available to other researchers upon request. Human subjects' rights to privacy will be protected and the identity of human subjects will not be revealed with any request.
Related trials for Smell Dysfunction
Not yet recruitingEarly Phase 1
In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
Endonasal Surgery, Endoscopic Sinus Surgery
RecruitingPhase 2
Impact of Smell Testing on Health Outcomes
Olfactory Dysfunction, Wellbeing
RecruitingPhase 3
Topical Versus Injection PRP for Olfactory Dysfunction
Olfactory Dysfunction, Anosmia
Not yet recruiting
Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial
Post-traumatic Olfactory Dysfunction, Traumatic Brain Injury
Not yet recruiting
Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction
Chronic Rhinosinusitis (CRS), Olfactory Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trigeminal Nerve Stimulation (TNS) and Active Smell Training (ST) in people with Smell Dysfunction and Olfactory Disorder, run by Medical University of South Carolina at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernadette M. Cortese, Ph.D. (843-792-6922, corteseb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks (time frame: 2 times: 4 weeks, 12 weeks). 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 2 Apr 2026.