Sonu for Pediatric Nasal Congestion

Overseen By Katie DeSutter

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Third Wave Therapeutics

Disqualifiers: Recent surgery, Sinus infection, Nasal polyposis, Pregnancy

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 children and young adults with moderate to severe nasal congestion. The focus is on individuals who have experienced stuffy noses for at least a month. Those between 12 and 21 years old who find that nasal congestion affects daily life might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance treatment options for nasal congestion.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Sonu is safe for pediatric patients with nasal congestion?

Research has shown that Sonu is a safe choice for treating stuffy noses in children. Earlier studies reported no negative effects in any group using Sonu. The FDA has approved this device for children aged 12 and up, indicating it has passed safety tests for use in this age group. By not using drugs, the device reduces the risk of side effects often associated with medications. Overall, Sonu appears well-tolerated and offers a promising solution for children with nasal congestion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for pediatric nasal congestion, which often rely on decongestants or antihistamines to relieve symptoms, Sonu offers a novel approach. Researchers are excited about Sonu because it introduces a unique delivery method, potentially offering faster relief by directly targeting nasal passages. This innovative approach could mean fewer side effects and a more comfortable experience for young patients, setting it apart from current options.

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

Research has shown that Sonu effectively relieves nasal congestion in children. This trial divides participants into two age groups: 12 to 15 years and 16 to 21 years. In one study, children aged 12 to 15 demonstrated an average improvement in their symptoms, with their Total Nasal Symptom Score (TNSS) dropping by 2.42 points over two weeks. Similarly, those aged 16 to 21 experienced an average TNSS decrease of 3.03 points. Over 80% of users reported feeling better within just 15 minutes. Sonu is also the first FDA-approved, drug-free wearable device for nasal congestion in children. These findings suggest that Sonu can significantly reduce nasal congestion in young patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Alan Greene, MD

Principal Investigator

Crescendo MD

Are You a Good Fit for This Trial?

This trial is for kids and young adults aged 12 to 21 who've had a stuffy nose for at least a month. They should score at least 2 out of 3 on a nasal congestion scale. It's not for those who've had recent head or sinus surgery, current sinus infections, medication-related congestion, are pregnant, or have nasal growths.

Inclusion Criteria

I have moderate to severe nasal congestion.

I am between 12 and 21 years old.

I have had nasal congestion for at least 1 month.

Exclusion Criteria

I have not had head, nasal, or sinus surgery in the last 3 months.

I was diagnosed with a sinus infection recently or have medication-induced nasal congestion.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sonu Acoustic Resonance Therapy for the treatment of nasal congestion

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

Trial Overview The trial tests Sonu therapy which uses sound waves to treat moderate to severe stuffed noses in children. The goal is to see if it's safe and works well as a new treatment option.

How Is the Trial Designed?

Group I: Ages 16-21 Experimental Treatment 1 Intervention

Pediatric subjects aged 16-21 years

Group II: Ages 12-15 Experimental Treatment 1 Intervention

Pediatric subjects aged 12-15 years

Who Is Running the Clinical Trial?

Third Wave Therapeutics

Lead Sponsor

Trials

5

Recruited

280+

Published Research Related to This Trial

Acoustic rhinometry (AR) is a non-invasive and quick method for assessing nasal airways in infants and small children, providing reliable measurements that correlate well with traditional imaging techniques like CT scans.

While AR offers significant advantages for evaluating nasal airway dimensions in pediatric populations, the paper also highlights its limitations and potential sources of error, emphasizing the need for careful measurement and data interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic rhinometry in infants and children. Djupesland, P., Pedersen, OF.[2008]

Chronic nasal symptoms in children often persist despite treatment with intranasal steroids, antihistamines, and leukotriene receptor antagonists, indicating a need for better diagnostic and management strategies.

For children who do not respond to medical therapy, surgical options like turbinate reduction have shown significant improvements in quality of life, suggesting they may be effective for managing persistent nasal dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic nasal dysfunction in children: Allergic rhinitis? Infectious? What to do if neither? Wei, JL.[2022]

The combination treatment of azelastine hydrochloride and fluticasone propionate has been shown to be effective and safe for treating allergic rhinitis in children and adolescents, based on a review of 12 clinical trials.

However, there is a need for more data specifically on the youngest children (ages 4 and 5 years), as their representation in existing studies was low, highlighting a gap in understanding the safety and efficacy for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with azelastine hydrochloride and fluticasone propionate in a single delivery device of young children and adolescents with allergic rhinitis. Berger, WE., Mustakov, TB., Kralimarkova, TZ., et al.[2021]

The new rhinometric probe designed for infants demonstrated excellent repeatability (CV < 0.6%) and high reproducibility (CV < 4%) under stable ambient conditions, making it a reliable tool for measuring nasal cavity dimensions.

Accuracy of measurements, such as the minimum cross-sectional area (MCA) and nasal cavity volume, was acceptable (% error < 12%) when specific conditions regarding MCA size and shape were met, ensuring the probe's clinical utility in assessing infant nasal passages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical abilities and limitations of acoustic rhinometry optimised for infants. Djupesland, PG., Lyholm, B.[2006]

A systematic review of 526 studies found no randomized controlled trials that met the criteria to evaluate the efficacy of decongestants, antihistamines, or nasal irrigation in children with acute sinusitis.

As a result, there is currently no evidence to support the use of these treatments for symptom relief in children diagnosed with acute sinusitis, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Shaikh, N., Wald, ER., Pi, M.[2020]

A systematic review of 402 studies found no randomized controlled trials that met the criteria to evaluate the efficacy of decongestants, antihistamines, or nasal irrigation in children with acute sinusitis.

As a result, there is currently no evidence to support the use of these treatments for symptom relief in children with acute sinusitis, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Shaikh, N., Wald, ER., Pi, M.[2018]

A study involving 40 children treated with a new nasal hypertonic spray (Narlisim™) for 4 days showed significant short-term efficacy in reducing nasal congestion and related symptoms from the common cold, with results indicating strong improvements at both 48 and 96 hours.

No adverse events were reported during the trial, highlighting the safety of this treatment, making it a promising option for managing nasal congestion in children under 12, who typically have limited safe treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pirometaxine™ (Narlisim™) in pediatric nasal congestion: a retrospective study. Tropi, G., Patanè, C., Leocata, RC., et al.[2019]

Intranasal steroids are beneficial for treating all types of adult rhinosinusitis, with some positive effects noted in acute pediatric cases, although evidence is limited for children.

Saline irrigation is effective for chronic rhinosinusitis without polyps and acute pediatric rhinosinusitis, but intranasal antifungals and antibiotics show no evidence of benefit and may cause harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Intranasal Medications in Rhinosinusitis. Snidvongs, K., Thanaviratananich, S.[2022]

In a study of 10 children aged 3 to 9 with chronic rhinosinusitis, daily nasal saline irrigation for one month led to a significant improvement in sinonasal symptoms, with the mean total score on the Sinus and Nasal Quality of Life Survey (SN-5) decreasing by 45%.

The treatment also resulted in a notable enhancement in overall nasal quality of life scores, with most patients showing good compliance, and only one patient requiring further surgical intervention during a follow-up period averaging over 10 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nasal saline lavage on pediatric sinusitis symptoms and disease-specific quality of life: a case series of 10 patients. Lin, SY., Baugher, KM., Brown, DJ., et al.[2019]

Surgical treatments for common pediatric otolaryngology conditions, like tympanostomy tube placement for otitis media and adenotonsillectomy for recurrent tonsillitis, significantly improve quality of life and health status for children.

Cochlear implantation in children is shown to be a very cost-effective intervention, highlighting its value in treating hearing loss in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes research in pediatric otolaryngology. Johnson, RF., Stewart, MG.[2019]

Intranasal corticosteroids are more effective than nasal saline irrigation for relieving allergic rhinitis symptoms in children, indicating that they should be the preferred treatment option.

Combination therapy using both intranasal corticosteroids and nasal saline further enhances symptom relief, suggesting that using multiple approaches can provide better outcomes for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Question: Nasal saline or intranasal corticosteroids to treat allergic rhinitis in children. Madison, S., Brown, EA., Franklin, R., et al.[2018]

A systematic review of 662 studies found no randomized controlled trials that met the criteria to evaluate the efficacy of decongestants, antihistamines, or nasal irrigation in treating acute sinusitis in children.

As a result, there is currently no evidence to support the use of these treatments for improving symptoms of acute sinusitis in children, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Shaikh, N., Wald, ER.[2022]

In a study analyzing 911 adverse reactions associated with dupilumab for chronic rhinosinusitis with nasal polyps (CRSwNP), it was found that this treatment had fewer individual adverse reactions (iDAR) compared to treatments for asthma and atopic dermatitis, suggesting a favorable safety profile.

However, serious adverse reactions were reported in 13.3% of cases, with a notable risk among men and older adults, indicating that while dupilumab is generally safe, certain populations may experience more severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of FDA Adverse Event Reporting System. Swisher, AR., Kshirsagar, RS., Adappa, ND., et al.[2022]

A modified acoustic rhinometry (AR) device, designed for infants and children, accurately measures nasal cavity configurations, showing a strong correlation (r = .88) with traditional measurement methods using nasal casts.

In a study of 10 normal, term infants, the modified AR provided reliable measurements of nasal valve area and total nasal volume, indicating its potential use for airway research and screening for nasal patency in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal cavity area in term infants determined by acoustic rhinometry. Buenting, JE., Dalston, RM., Drake, AF.[2007]

Citations

1. 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.

2. empr.com empr.com/news/fda-clears-wearable-device-to-treat-nasal-congestion-in-children/

FDA Clears Wearable Device to Treat Nasal Congestion in ... Over a 2-week period, findings showed treatment with Sonu resulted in a mean change in TNSS of -2.42 for the 12 to 15 year old group and -3.03 ...

3. drugs.com drugs.com/news/fda-approves-sonu-band-free-pediatric-nasal-congestion-125337.html

FDA Approves Sonu Band for Drug-Free Treatment of ... Clinical data show that over 80 percent of Sonu patients reported improvement in their nasal symptoms in 15 minutes or less. The Sonu app ...

4. contemporarypediatrics.com contemporarypediatrics.com/view/fda-approves-pediatric-indication-for-sonu-wearable-device-to-treat-nasal-congestion

FDA approves pediatric indication for SONU wearable ... The AI-enabled, wearable device is the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06773013/safety-and-effectiveness-of-sonu-for-pediatric-nasal-congestion

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.

6. withpower.com withpower.com/trial/sonu-for-pediatric-nasal-congestion-ed54d

Sonu for Pediatric Nasal Congestion · Info for Participants The combination of azelastine hydrochloride and fluticasone propionate, which may be similar to Sonu, has been shown to be safe in clinical trials involving ...