Nasal Congestion and InflammationsNCT06773013
Safety and Effectiveness of Sonu for Pediatric Nasal Congestion
A study testing Acoustic Resonance (Sound) Therapy 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 pediatric patients with moderate to severe nasal congestion. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Nasal Congestion and Inflammations
- What is being tested?
- Acoustic Resonance (Sound) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 30 Mar 2025
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric subjects between the ages of 12 to 21 years
- 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
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.
To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
- Conditions
- Nasal Congestion and Inflammations
- Being tested
- Acoustic Resonance (Sound) Therapy
- 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.
Acoustic Resonance (Sound) TherapyDevice
Sonu consists of an acoustic Vibrational Headband worn circumferentially at the level of the forehead; and a Smartphone App, paired to the Headband. The App determines acoustic resonant frequencies of the subject's nasal cavity (using the facial image) and delivers treatment through bone conduction transducers in the headband
| Study group | Role | What they receive |
|---|---|---|
| Ages 12-15 | Other | Pediatric subjects aged 12-15 years Receives: Device: Acoustic Resonance (Sound) Therapy |
| Ages 16-21 | Other | Pediatric subjects aged 16-21 years Receives: Device: Acoustic Resonance (Sound) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Safety
Measured: 2 weeks
Reduction in nasal congestion subscore
Effectiveness
Measured: 2 weeks
Secondary outcomes (2)
Adverse events
Safety
Measured: 2 weeks
Total Nasal Symptom Score (TNSS)
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 posted14 Jan 2025
- Study start9 Jan 2025
- Primary completion16 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Wave Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Greene, MD, Principal investigator, Crescendo MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773013
- Sponsor's protocol ID
- CP-008
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Luong AU, Yong M, Hwang PH, Lin BY, Gopi P, Mohan V, Ma Y, Johnson J, Yen DM, DeMera RS, Bleier BS. Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham-controlled trial. Int Forum Allergy Rhinol. 2024 May;14(5):919-927. doi: 10.1002/alr.23284. Epub 2023 Oct 9.
PubMed 37812532
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.
- ClinicalTrials.gov ID
- NCT06773013
- Acronym / sponsor ID
- CP-008
- Conditions
- Nasal Congestion and Inflammations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Third Wave TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Jan 2025 (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.
To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ages 12-15 | Other | Device: Acoustic Resonance (Sound) TherapyPediatric subjects aged 12-15 years |
| Ages 16-21 | Other | Device: Acoustic Resonance (Sound) TherapyPediatric subjects aged 16-21 years |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric subjects between the ages of 12 to 21 years
- 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 (4 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
- 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 |
|---|---|---|
| Acoustic Resonance (Sound) TherapySonu consists of an acoustic Vibrational Headband worn circumferentially at the level of the forehead; and a Smartphone App, paired to the Headband. The App determines acoustic resonant frequencies of the subject's nasal cavity (using the facial image) and delivers treatment through bone conduction transducers in the headband | Device | Ages 12-15, Ages 16-21 |
Primary outcome
Serious adverse events
Time frame: 2 weeks
Safety
Reduction in nasal congestion subscore
Time frame: 2 weeks
Effectiveness
2 secondary outcomes
Adverse events
Time frame: 2 weeks
Total Nasal Symptom Score (TNSS)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 37812532Luong AU, Yong M, Hwang PH, Lin BY, Gopi P, Mohan V, Ma Y, Johnson J, Yen DM, DeMera RS, Bleier BS. Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham-controlled trial. Int Forum Allergy Rhinol. 2024 May;14(5):919-927. doi: 10.1002/alr.23284. Epub 2023 Oct 9.
- 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.
Alan Greene, MD principal investigator
Crescendo MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic Resonance (Sound) Therapy 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 4 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 10 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious adverse events (time frame: 2 weeks). 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?
On the ClinicalTrials.gov record for NCT06773013, which also lists 1 linked publication.
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 10 Sep 2025.