Sonu for Nasal Obstruction

(SCORE Trial)

Overseen By Paramesh Gopi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Third Wave Therapeutics

Disqualifiers: Recent surgery, Sinus infection, Nasal polyposis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a treatment called Sonu for individuals with moderate to severe nasal congestion. Participants will be divided into two groups. One group will receive the actual Sonu treatment, which uses sound waves to alleviate congestion, while the other group will receive a placebo for comparison. Those experiencing a stuffy nose for at least a month and finding it bothersome daily might find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for nasal congestion.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Sonu, which uses sound therapy, is safe for treating stuffy noses. Research found that people using Sonu reported no side effects. The FDA has approved Sonu for use, indicating it meets safety standards. This device operates without causing harm, making it a promising option for those with moderate to severe nasal congestion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sonu because it offers a novel approach to treating nasal congestion. Unlike traditional treatments like decongestant sprays or antihistamines, which often focus on reducing inflammation or blocking histamines, Sonu uses acoustic resonance therapy. This innovative method involves delivering sound waves to relieve congestion, potentially offering a drug-free alternative that avoids common side effects. Additionally, Sonu's non-invasive delivery method could make it a convenient option for those seeking quick relief without the need for medication.

What evidence suggests that Sonu might be an effective treatment for nasal congestion?

Research shows that Sonu, a therapy using sound waves, has promising results for treating stuffy noses. In this trial, participants in the Sonu Treatment Group will receive acoustic resonance therapy. Previous studies have shown that 84.6% of people who received this therapy felt better, compared to 65.4% in the group that did not. Another study found that 90% of participants noticed an improvement in their congestion after just two sessions. Comparisons with other nasal treatments indicate that Sonu is just as effective and has no side effects. These findings suggest that Sonu could be a safe and effective way to relieve nasal congestion. ^{1 2 3 4 6}

Who Is on the Research Team?

Jacob Johnson, MD

Principal Investigator

San Francisco Otolaryngology Medical Group

Are You a Good Fit for This Trial?

Inclusion Criteria

You experience at least two hours of nasal congestion within a 24 hour period.

You have experienced a prolonged bout of nasal congestion prior to commencing treatment.

Exclusion Criteria

Head, nasal or sinus surgery within 3 months

You have a history of growths or masses in your nose.

You had a sinus infection or used certain nose medications in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acoustic resonance therapy or non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sonu

How Is the Trial Designed?

Group I: Sonu Treatment Group Experimental Treatment 1 Intervention

Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.

Group II: Sham Control Group Placebo Group 1 Intervention

Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.

Who Is Running the Clinical Trial?

Third Wave Therapeutics

Lead Sponsor

Trials

5

Recruited

280+

Published Research Related to This Trial

The ExtractEHR automated package effectively identified and graded laboratory adverse events in a cohort of 1,077 children with acute myeloid leukaemia and acute lymphoblastic leukaemia, demonstrating its scalability and accuracy in capturing adverse event rates.

The study found that ExtractEHR reported significantly higher rates of laboratory adverse events compared to those manually reported in clinical trials, suggesting that automated systems can enhance the understanding of chemotherapy risks in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group. Miller, TP., Getz, KD., Li, Y., et al.[2023]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

A new online toxicity registration strategy was developed for children and young adults treated under the Nordic/Baltic acute lymphoblastic leukaemia protocol, which streamlined the process and achieved a high compliance rate of 98.9% within 5 weeks.

This approach focuses on monitoring serious but rare adverse events, allowing for real-time toxicity profiles and early warnings for specific toxicities, which can enhance patient safety and inform treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial. Frandsen, TL., Heyman, M., Abrahamsson, J., et al.[2019]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/alr.23284

Acoustic resonance therapy is safe and effective for the ... When examining overall TNSS, the ART group response rate was 84.6% compared to 65.4% for the sham group (p = 0.11). The ART group had a 29% ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN230045.pdf

DEN230045, Sonu, Sound Health Systems, Inc. In conclusion, the results from this clinical study report demonstrate that Sonu is safe and effective for use at home for the treatment of ...

3. advances.massgeneral.org advances.massgeneral.org/otolaryngology/journal.aspx?id=2586

Acoustic Resonance Therapy Safe for Rhinitis-related ... An investigational ART headband, Sonu (Sound Health Systems, Los Altos, CA), improved nasal congestion after just two 10-minute sessions in 90% of subjects in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06773013

Safety and Effectiveness of Sonu for Pediatric Nasal ... To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.

5. healio.com healio.com/news/allergy-asthma/20250624/qa-fda-expands-approval-of-wearable-device-to-treat-nasal-congestion-in-adolescents

Q&A: FDA expands approval of wearable device to treat ... The results showed that SONU was as effective if not better across the spectrum of pharmaceutical interventions with zero side effects. SONU is ...

6. empr.com empr.com/home/news/fda-cleared-device-delivers-acoustic-resonance-therapy-to-treat-nasal-congestion/

FDA-Cleared Device Delivers Acoustic Resonance ... Cleared by the Food and Drug Administration in 2023, this AI-enabled wearable device is indicated for at-home use by individuals aged 22 years ...