Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

(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

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Sonu, a headband that uses sound vibrations from a smartphone app, to help people with severe nasal congestion due to rhinitis. The vibrations aim to clear the nasal passages and make breathing easier. The device has been studied for its effectiveness in reducing 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.

What safety data exists for the treatment known as Sonu?

The available research highlights the importance of collecting and analyzing safety data in clinical trials, but it does not provide specific safety information about the treatment known as Sonu. It emphasizes the need for standardized safety data collection and reporting to better understand potential side effects. ^{1 2 3 4 5}

Research Team

Jacob Johnson, MD

Principal Investigator

San Francisco Otolaryngology Medical Group

Eligibility Criteria

Inclusion Criteria

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

You must be at least 18 years of age to participate in this study.

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

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

Treatment Details

Interventions

• Sonu

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Standardized retrieval of side effects data for meta-analysis of safety outcomes. A feasibility study in acute sinusitis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

3. England 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. [2021]

4. England 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. [2023]

5. England 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. [2019]