Nasal Congestion and InflammationsSCORENCT05821842
Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
A study testing Sonu in people with Nasal Congestion and Inflammations, run by Third Wave Therapeutics at 1 site in United States.
Trial summary
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Congestion and Inflammations
- What is being tested?
- Sonu
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Present with symptoms of nasal congestion for 1 month or more prior to treatment
- Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
Who cannot join
- Head, nasal or sinus surgery within 3 months
- Sinus infection diagnosed within the last month, or rhinitis medicamentosa
- Documented history of nasal polyposis or mass
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108
About this study
Official title: Sonu Nasal COngestion RElief Study (SCORE)
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
Read the detailed description
Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.
- Conditions
- Nasal Congestion and Inflammations
- Being tested
- Sonu
- Medical subject headings
- Nasal Obstruction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonuDevice
Acoustic energy delivery
| Study group | Role | What they receive |
|---|---|---|
| Sonu Treatment Group | Experimental | Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Receives: Device: Sonu |
| Sham Control Group | Sham comparator | Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Receives: Device: Sonu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness
Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.
Measured: 2 weeks
Secondary outcomes (1)
Secondary Effectiveness
Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start23 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal Congestion and InflammationsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Wave Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Johnson, MD, Principal investigator, San Francisco Otolaryngology Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821842
- Sponsor's protocol ID
- CP-002
- Acronym
- SCORE
- Status last verified
- Sep 2023
- First submitted
- 7 Apr 2023
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonu Nasal COngestion RElief Study (SCORE)
- ClinicalTrials.gov ID
- NCT05821842
- Acronym / sponsor ID
- SCORE / CP-002
- Conditions
- Nasal Congestion and Inflammations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Third Wave TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
Detailed description
Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonu Treatment Group | Experimental | Device: SonuPatients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. |
| Sham Control Group | Sham comparator | Device: SonuPatients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Present with symptoms of nasal congestion for 1 month or more prior to treatment
- Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
Key exclusion criteria (3 listed)
- Head, nasal or sinus surgery within 3 months
- Sinus infection diagnosed within the last month, or rhinitis medicamentosa
- Documented history of nasal polyposis or mass
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 |
|---|---|---|
| SonuAcoustic energy delivery | Device | Sham Control Group, Sonu Treatment Group |
Primary outcome
Primary Effectiveness
Time frame: 2 weeks
Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.
1 secondary outcome
Secondary Effectiveness
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Jacob Johnson, MD principal investigator
San Francisco Otolaryngology Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonu in people with Nasal Congestion and Inflammations, run by Third Wave Therapeutics 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Apr 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness (time frame: 2 weeks). 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 26 Apr 2024.