Nasal CongestionNCT06024564
Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
A study testing Sonu Acoustic Resonance Therapy in people with Nasal Congestion, run by Third Wave Therapeutics at 1 site in United States.
Trial summary
Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Sonu Acoustic Resonance Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 31 Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Present with symptoms of chronic nasal congestion
- 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
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108
About this study
Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion
Read the detailed description
This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion
- Conditions
- Nasal Congestion
- Being tested
- Sonu Acoustic Resonance Therapy
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonu Acoustic Resonance TherapyDevice
Participants will receive Sonu treatment twice a day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days Receives: Device: Sonu Acoustic Resonance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Utilization-Frequency
Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week
Measured: 90 days
Weekly Utilization-Duration
Weekly utilization of Sonu treatment, measured as the duration of treatment received per week
Measured: 90 days
Secondary outcomes (2)
Total Nasal Symptom Score (TNSS)
24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms.
Measured: 90 days
Asthma Control
Asthma Control Test (ACT) Score; Minimum score = 5 (poor control of asthma). Maximum score = 25 (complete control of asthma). Higher scores reflect greater asthma control.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start8 Aug 2023
- Primary completion31 May 2024
- Study completion31 Aug 2024
Why it stopped: Business/strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 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
- NCT06024564
- Sponsor's protocol ID
- CP-007
- Status last verified
- Dec 2024
- First submitted
- 27 Aug 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
- ClinicalTrials.gov ID
- NCT06024564
- Acronym / sponsor ID
- CP-007
- Conditions
- Nasal Congestion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business/strategic decision
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Third Wave TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 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.
Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion
Detailed description
This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Sonu Acoustic Resonance TherapyParticipants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days |
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 chronic nasal congestion
- 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 (2 listed)
- Head, nasal or sinus surgery within 3 months
- Pregnancy
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 |
|---|---|---|
| Sonu Acoustic Resonance TherapyParticipants will receive Sonu treatment twice a day for 90 days | Device | Interventional |
Primary outcome
Weekly Utilization-Frequency
Time frame: 90 days
Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week
Weekly Utilization-Duration
Time frame: 90 days
Weekly utilization of Sonu treatment, measured as the duration of treatment received per week
2 secondary outcomes
Total Nasal Symptom Score (TNSS)
Time frame: 90 days
Asthma Control
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Business/strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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Observational Study of RHINOSEDAL in Acute Nasal Obstruction
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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.
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 Acoustic Resonance Therapy in people with Nasal Congestion, 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 2 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: stopped early, as of the sponsor's last update on 1 Jan 2025. 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. 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?
The study was stopped early (reason given: Business/strategic decision). Results are not available in the source record.
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?
Weekly Utilization-Frequency (time frame: 90 days). The study lists 2 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 1 Jan 2025.