SinuSonic for Nasal Congestion

Overseen By Keri J Heilman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Asthma, COPD, Heart disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the SinuSonic device can improve physical and mental well-being in individuals with chronic nasal congestion. Researchers aim to determine if using the device twice daily for five weeks can reduce congestion and alleviate anxiety or depression associated with it. They are also examining the connection between stress reactions, such as anxiety, and nasal issues. The trial is suitable for U.S. residents who have experienced bothersome nasal congestion for at least two weeks and have not previously used the SinuSonic. As an unphased trial, it offers a unique opportunity to contribute to understanding how innovative devices can enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators for guidance.

What prior data suggests that the SinuSonic device is safe for nasal congestion?

Research has shown that the SinuSonic device is safe for people with stuffy noses. Earlier studies found no cases of bleeding and only minor discomfort when using the device. Most participants even expressed willingness to use it again. These results suggest that the SinuSonic is easy to use, with few reported side effects. Overall, the evidence supports its safety for treating nasal congestion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SinuSonic is unique because it uses acoustic vibrations and gentle pressure to alleviate nasal congestion, offering a novel approach compared to traditional treatments like decongestants and nasal sprays. Unlike other options that primarily use medication to reduce inflammation or constrict blood vessels, SinuSonic's method is drug-free and non-invasive, making it an attractive option for those seeking alternative therapies. Researchers are excited about its potential to provide relief without the side effects associated with medication, and its ease of use – just a couple of minutes twice a day – could improve patient adherence to treatment.

What evidence suggests that the SinuSonic device is effective for nasal congestion?

Research has shown that SinuSonic, the treatment under study in this trial, helps reduce nasal congestion. One study found that after five weeks, participants reported a decrease in congestion, with symptoms improving from a score of 5.8 to 2.6 on a simple scale. Another study found that overall nasal symptoms improved, with scores dropping from 7.2 to 3.5. Participants also reported no discomfort while using the device. These findings suggest that SinuSonic can provide significant relief for those with ongoing nasal congestion. ^{1 2 6 7 8}

Who Is on the Research Team?

Keri J Heilman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults with chronic nasal congestion who want to test a device called SinuSonic. It's designed to see if it can improve their physical and mental well-being. People with ongoing sinus issues, inflammation, or psychological impacts from nasal congestion may qualify.

Inclusion Criteria

I have had a blocked nose for over 2 weeks, and it's quite severe.

US resident

Exclusion Criteria

Previous use of the SinuSonic device

Pregnant or nursing women

I have or had heart or circulation problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Research Session

Participants complete self-report measures of physical health, mental health, autonomic regulation, and adverse experiences

1 session

1 visit (virtual)

Treatment

Participants use SinuSonic twice daily for 5 weeks and complete weekly forms to document usage and symptoms

5 weeks

Remote monitoring

Post-intervention Research Session

Participants complete self-report measures of symptoms, autonomic reactivity, and anxiety/depression after 5 weeks of SinuSonic use

1 session

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SinuSonic

Trial Overview The study tests the SinuSonic device on adults with chronic nasal congestion over five weeks. It measures changes in physical health, anxiety, depression, and autonomic reactivity (how the nervous system controls body functions) before and after using the device.

How Is the Trial Designed?

Group I: SinuSonic Experimental Treatment 1 Intervention

Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes.

SinuSonic is already approved in United States for the following indications:

Approved in United States as SinuSonic for:

• Nasal congestion
• Sinus congestion
• Allergies
• Rhinologic symptoms

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Healthy Humming, LLC

Industry Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study involving 92 patients with persistent nasal congestion, treatment with Narivent(®) for either 7 or 30 days resulted in significant improvements in both subjective and objective measures of nasal congestion.

No adverse effects were reported, indicating that Narivent(®) is a safe and effective option for alleviating nasal congestion in patients with various nasal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-centre, before-after study of the short- and long-term efficacy of Narivent(®) in the treatment of nasal congestion. Damiani, V., Camaioni, A., Viti, C., et al.[2017]

In a study of 69 children with acute sinusitis, normal saline nasal irrigation significantly improved quality of life and nasal function, as measured by the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire and nasal peak expiratory flow rate, compared to a control group.

The nasal irrigation was particularly effective in children with allergies, leading to significant improvements in symptoms like rhinorrhea, nasal congestion, and sleep quality, suggesting it is a beneficial adjunctive treatment for pediatric acute sinusitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nasal irrigation in the treatment of acute sinusitis in children. Wang, YH., Yang, CP., Ku, MS., et al.[2015]

Nasal saline irrigation is effective for improving mucociliary transport and removing debris in rhinosinusitis and post-surgical care, and this study used computational fluid dynamics to analyze how different factors affect saline flow in the nasal passages.

The research found that the best results for filling the maxillary sinuses with saline occurred when the irrigation was directed into the open nostril while the head was tilted back, highlighting the importance of head position and inflow direction in maximizing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neti pot irrigation volume filling simulation using anatomically accurate in-vivo nasal airway geometry. Salati, H., Bartley, J., Yazdi, SG., et al.[2021]

Computational fluid dynamics (CFD) studies have revealed that larger ostial sizes significantly enhance sinus ventilation and the delivery of medications, which can improve patient outcomes in chronic rhinosinusitis (CRS).

CFD has also shown that optimizing nasal spray parameters, such as particle size and delivery technique, can greatly increase the effectiveness of topical treatments, suggesting that tailored approaches could lead to better management of CRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can computational fluid dynamic models help us in the treatment of chronic rhinosinusitis. Singh, NP., Inthavong, K.[2021]

In a study of 30 participants, daily betamethasone nasal irrigation for six weeks significantly improved symptoms of chronic rhinosinusitis, as measured by the Sino-Nasal Outcome Test, with 63% of participants achieving clinically meaningful improvements.

The treatment did not significantly alter morning serum cortisol levels, and while there was a decrease in 24-hour urinary free cortisol, this change was considered clinically negligible, indicating that betamethasone nasal irrigation is a safe option for patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of nasal lavage with betamethasone cream post-endoscopic sinus surgery: clinical trial. Dawson, B., Gutteridge, I., Cervin, A., et al.[2018]

A pilot study using computational fluid dynamics (CFD) simulations showed that endoscopic sinus surgery significantly improved irrigation of the frontal sinus, which is crucial for postoperative recovery.

However, the surgery also led to reduced irrigation penetration in the maxillary and ethmoid sinuses, likely due to changes in anatomy from the surgical procedure, highlighting the need for tailored irrigation strategies post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sinus irrigations before and after surgery-Visualization through computational fluid dynamics simulations. Zhao, K., Craig, JR., Cohen, NA., et al.[2018]

Saline nasal irrigation is an effective adjunctive therapy for managing symptoms of chronic rhinosinusitis, with consensus guidelines supporting its use for various upper respiratory conditions.

The procedure is considered safe, with no serious adverse events reported, and minor side effects can be minimized through proper technique and salinity adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for upper respiratory conditions. Rabago, D., Zgierska, A.[2021]

In a study of 40 patients with allergic rhinitis, adding large-volume, low-pressure nasal irrigation with isotonic saline to existing intranasal corticosteroid therapy significantly improved quality of life, as measured by the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (mRQLQ).

The mRQLQ scores decreased from an average of 36.7 at baseline to 10.1 after 8 weeks of treatment, indicating a substantial improvement, while no significant changes were observed in nasal peak inspiratory flow or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. Nguyen, SA., Psaltis, AJ., Schlosser, RJ.[2022]

Nasal saline irrigation is commonly used for managing conditions like allergic rhinitis and rhinosinusitis, but previous studies have overlooked important factors such as the nasal cycle's impact on nasal geometry and resistance.

The review highlights that existing studies primarily focus on irrigation coverage without considering how nasal airflow dynamics could affect treatment efficacy, suggesting that new computational models could enhance clinical practices for nasal irrigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline irrigation - A review of current anatomical, clinical and computational modelling approaches. Salati, H., Bartley, J., White, DE.[2021]

Oral vasoconstrictors like ephedrine can effectively treat nasal congestion caused by cold and flu viruses, but they must be prescribed cautiously due to contraindications with certain medications and health conditions.

Alternative treatments such as aromatic volatile oils (like menthol and eucalyptus) can be used safely as rubs or inhalants, especially for young children, but should be applied according to manufacturer guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remedies for common family ailments: 10. Nasal decongestants. Sinclair, A.[2004]

In a study involving 5 cadavers, balloon dilation of sinus ostia significantly increased the minimum ostial dimension from 1.73 mm to 3.6 mm, which improved irrigation penetration into the sphenoid sinus, indicating that larger ostial sizes enhance treatment efficacy.

However, the study also found that guidewire insertion often created false passages during maxillary sinus dilation, leading to decreased irrigant penetration in the maxillary sinuses after dilation, highlighting the importance of technique in sinus irrigation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unexpected consequences of transnasal balloon dilation of the maxillary ostium. Brenner, PS., Abadie, WM., Weitzel, EK., et al.[2016]

Nasal surgery is effective in improving symptoms for many patients with rhinosinusitis who have not responded to medical treatments, as it helps relieve obstruction and restore mucociliary clearance.

Computational modeling has been used to study the changes in nasal structure and function post-surgery, but more research is needed to connect these models to actual patient outcomes and improve surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: The role of computational simulation in understanding the postoperative sinonasal environment. Kumar, H., Jain, R.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6718060/

The SinuSonic: reducing nasal congestion with acoustic ... Overall, outcomes were encouraging from this small pilot study with effect sizes in the moderate to large range and no reports of discomfort. It ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03906968

The Safety and Efficacy of a SinuSonic Intervention This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7317541/

A novel device combining acoustic vibration with oscillating ... At the 5 week follow‐up, nasal congestion VAS improved from mean ± SD of 5.8 ± 2.4 to 2.6 ± 2.3, TNSS improved from 7.2 ± 3.5 to 3.5 ± 3.1, NOSE ...

4. sinusonic.com sinusonic.com/blogs/news/sinusonic-announces-presentation-of-double-blind-sham-controlled-trial-data-showing-regular-use-of-the-device-improved-nasal-congestion?srsltid=AfmBOooRdhvAGpPwPfbXRIu9Sfyau_vUUXg2DG36yDChM3ndpjkFOV22

SinuSonic Announces Presentation of Double-Blind, Sham ... My doctor now uses it herself...I have been using Sinusonic for 3 years and it has been a miracle for me. I suffered terribly for decades with ...

5. biospace.com biospace.com/sinusonic-announces-publication-of-study-results-on-first-of-its-kind-medical-device-for-natural-relief-of-nasal-congestion

SinuSonic Announces Publication of Study Results on First ... SinuSonic announced today publication of safety and effectiveness data of the company's device.

6. news-medical.net news-medical.net/news/20191203/Clinical-trial-data-demonstrates-safety-and-efficacy-of-nasal-congestion-treatment-device.aspx

Clinical trial data demonstrates safety and efficacy of nasal ... Clinical trial data demonstrates safety and efficacy of nasal congestion treatment device ... SinuSonic for the treatment of nasal congestion ...

7. sinusonic.com sinusonic.com/blogs/news/sinusonic-announces-publication-of-study-results-on-first-of-its-kind-medical-device-for-natural-relief-of-nasal-congestion?srsltid=AfmBOootzAXxzTSs7k20wN2hk73HxowcO1UwNT6Hzyi_hKAMZ10yBLQT

SinuSonic Publishes Result on First of Its Kind Medical ... SinuSonic announced today publication of safety and effectiveness data of the company's device.

8. ctv.veeva.com ctv.veeva.com/study/effects-of-sinusonic-on-psychological-and-physical-well-being

Effects of SinuSonic on Psychological and Physical Well-Being The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who ...