Nasal Plug for Nasal Congestion

Overseen By Beth Miles-Markley, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Congenital olfactory losses, Nasal polyps, Cystic fibrosis, Connective tissue disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with nasal congestion and smell loss by testing a new nasal plug device. The plug, inserted into the nose, changes airflow, potentially easing symptoms. Participants should experience nasal obstruction and smell issues. The trial seeks to develop better tools for managing these symptoms, allowing for more personalized treatment choices. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for nasal congestion and smell loss.

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 prior data suggests that this nasal plug is safe for nasal congestion?

Research has shown that similar devices for treating stuffy noses are safe. One study found that a device used for 20 minutes caused no adverse side effects and was easy for participants to use. Although specific safety data for the Nasal Plug treatment is not yet available, the absence of negative effects in similar devices suggests it might be safe. However, the trial phase for the Nasal Plug is "Not Applicable," indicating limited direct safety evidence for this device. As with any new treatment, staying informed and consulting a doctor before joining the trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for nasal congestion, like decongestant sprays and oral medications, work by reducing swelling in the nasal passages. But the nasal plug is different because it uses a mechanical approach to address congestion. This device is self-inserted and features a diagonal channel that redirects airflow to optimize breathing through different nasal regions. Researchers are excited about this treatment because it offers a drug-free alternative that could provide quick relief without the potential side effects associated with medications.

What evidence suggests that this nasal plug is effective for nasal congestion?

Research has shown that the nasal plug used in this trial can significantly alleviate nasal congestion. In one study, participants reported a notable decrease in congestion, with their scores dropping from 12.5 to 5, a significant improvement (P=0.005). The nasal plug alters airflow in the nose, reducing the sensation of stuffiness. Early results suggest that using a nasal plug can ease nasal breathing for individuals with sinus issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Kai Zhao, Ph.D

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for adults who are experiencing smell loss and nasal obstruction, but not due to head trauma, congenital issues, significant atrophy, connective tissue disorders like Wegeners, nasal polyps blocking the olfactory cleft or cystic fibrosis.

Inclusion Criteria

I have experienced a loss of smell.

I have difficulty breathing through my nose.

Exclusion Criteria

I was born without the ability to smell.

I have nasal polyps blocking my sense of smell.

I have cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a self-inserted nasal plug device to modulate nasal airflow and trigeminal sensory feedback

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in nasal obstruction symptoms and other related outcomes

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nasal Plug

Trial Overview The study is developing new clinical tools to assess and manage symptoms of nasal sinus disease. It focuses on relieving nasal blockage and smell loss so patients can choose better treatment options.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

A device-nasal plug will be self-inserted into the nose with a diagonal channel embedded to redirect nasal airflow patterns to different nasal regions. A nose clip will be used to pinch the nose externally, similar to what synchronized swimmers use.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 16 adult patients undergoing L-shaped augmentation rhinoplasty, satisfaction with nasal aesthetics significantly improved, as indicated by a rise in the rhinoplasty outcomes evaluation (ROE) score from 7.00 to 14.00 post-surgery (P=0.001).

Nasal airway function also improved, with the nasal obstruction symptom evaluation (NOSE) score decreasing from 12.5 to 5 (P=0.005) and peak nasal inspiratory flowmeter (PNIF) scores increasing from 92 to 115, demonstrating that the procedure enhances both patient satisfaction and nasal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and Esthetic Outcomes of L-Shaped Augmentation Rhinoplasty in Indonesian Noses. Widodo, DW., Asmoro, SDP., Wardani, RS., et al.[2023]

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]

A study comparing over-the-counter normal saline and nasal decongestant drops for nasal congestion found no significant difference in effectiveness between the two treatments, with a p-value of 0.701671.

For patients on antibiotics, there was a significant difference in symptom relief when treated with nasal drops alone, indicating that oral medications may be more effective for overall relief of nasal congestion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Over-The-Counter Intranasal Preparations: A Randomized Trial. Deve, L., Poduval, J.[2020]

A systematic review of 10 studies involving 209 pediatric patients found that topical intranasal decongestants like phenylephrine and oxymetazoline have minimal and mostly self-limiting side effects, such as bradycardia and hypertension, with only 1.9% of patients requiring treatment for these effects.

No mortality was reported, indicating that when used in controlled dosages, these decongestants are generally safe for pediatric patients, although further research is needed to establish optimal dosing guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical administration of nasal decongestants and vasoconstrictors in paediatric nasal surgery - A systematic review. Macmillan, AJ., Phoon, KM., Edafe, O.[2022]

Topical nasal decongestant sprays are effective in reducing nasal airway resistance (NAR), providing symptomatic relief for nasal obstruction commonly associated with the common cold.

Nasal obstruction is a widespread issue, and these sprays can significantly improve breathing comfort during cold symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paradoxical increase in nasal airway resistance following a topical nasal decongestant spray. Doddi, NM., Eccles, R.[2021]

A study conducted in Unaizah Al-Qassim province, Saudi Arabia, revealed that only 16.6% of 385 participants were aware of the side effects of nasal decongestants, indicating a significant lack of knowledge about these commonly used medications.

Despite 64.4% of participants having used nasal decongestants, awareness of safe usage guidelines and potential risks, such as addiction, was low, highlighting the need for educational campaigns to inform the public about the safe use of these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness of the Unaizah populations in Al-Qassim province in Saudi Arabia regarding nasal decongestant use for allergic rhinitis and their side effect. Almutairi, A., Almutairi, H., Althwiny, FA., et al.[2022]

A study involving 16 subjects showed that using the Nozovent nasal device significantly improved airflow through the nostrils, increasing the average airflow from 0.68 l/sec to 0.84 l/sec.

The improvement in airflow with the Nozovent device was comparable to the effects of using nasal drops, suggesting it could be a beneficial option for patients experiencing nasal resistance, especially during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of the nasal airflow by the nasal dilator Nozovent. Petruson, B.[2004]

Nasal dilators like Breathe Right and Nozovent effectively improve nasal airflow by stabilizing the nasal valves, particularly during inhalation, but individual responses can vary significantly, with potentially lower effectiveness in non-Caucasians.

These devices can help reduce snoring and improve breathing during sleep for certain patients, although identifying the right candidates may require sleep studies to assess their effectiveness with and without the dilators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical nasal alar dilators. Ellegård, E.[2007]

The new software program Odiosoft-Rhino (OR) effectively measures nasal airflow in patients with nasal septal deviation, showing significant differences in nasal obstruction compared to healthy controls, particularly in specific frequency ranges.

The OR test demonstrated high sensitivity (83.4%) and specificity (82.1%) for diagnosing nasal obstruction, suggesting it could be a reliable noninvasive diagnostic tool in clinical practice, although further studies are needed for validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of nasal obstruction with Odiosoft-Rhino in nasal septal deviation. Tahamiler, R., Canakcioglu, S.[2013]

Nasal congestion is a key symptom in diagnosing upper respiratory tract disorders, and while patient history and symptom assessment are crucial, current medications may not always provide adequate relief.

For persistent or severe cases, specialized diagnostic techniques like endoscopy, peak nasal inspiratory flow, and acoustic rhinometry can help identify underlying causes and measure treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic strategies in nasal congestion. Krouse, J., Lund, V., Fokkens, W., et al.[2021]

Intranasal saline sprays at room temperature (22 degrees C) cause a temporary vasoconstriction in the nasal passages, which may contribute to improved nasal comfort for patients with non-allergic chronic rhinosinusitis (NACRS).

This vasoconstriction also leads to a significant decrease in nasal nitric oxide levels, suggesting that the comfort experienced by patients using saline sprays could be linked to these physiological changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somato-sympathetic vasoconstriction to intranasal fluid administration with consecutive decrease in nasal nitric oxide. Landis, BN., Beghetti, M., Morel, DR., et al.[2015]

Nasal obstruction is a common issue with various causes, making treatment outcomes complex to measure; both objective assessments and patient-reported outcome measures (PROMs) are essential for evaluating symptom improvement.

Clinical guidelines recommend using PROMs for assessing surgical treatment outcomes in nasal obstruction, highlighting the importance of incorporating patient perspectives into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the Subjective Experience of Nasal Obstruction: A Review. Rossi Meyer, MK., Most, SP.[2023]

Citations

1. withpower.com withpower.com/trial/nasal-plug-for-nasal-congestion-abe19

Nasal Plug for Nasal Congestion Nasal airway function also improved, with the nasal obstruction symptom evaluation (NOSE) score decreasing from 12.5 to 5 (P=0.005) and peak nasal inspiratory ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7752074/

A multicenter survey on the effectiveness of nasal irrigation ... Nasal irrigation with high‐volume devices was an effective treatment for rhinosinusitis and was more effective at clearing nasal secretion and reducing post‐ ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03549130

A Pivotal Study to Assess the Effectiveness of Nasal Dilator ... This randomized, double-blind, parallel group, placebo-controlled study assessed subjective measures of nasal airway breathing immediately after application.

4. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2795563

Temperature-Controlled Radiofrequency Device Treatment ... Temperature-controlled radiofrequency device treatment of the nasal valve was associated with a sustained improvement in symptoms of nasal airway obstruction ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11024000/

A nasal airflow oscillation device targeting nasal congestion Treatment of nasal congestion with the nasal airflow oscillation device was found to result in significant improvement in NPIF after twenty minutes of use.

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-warns-abuse-and-misuse-nasal-decongestant-propylhexedrine-causes-serious-harm

Serious harm from abuse/misuse of nasal decongestant ... FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm. This includes heart and mental health ...

7. 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. Download PDF Copy. Editorial Checklist Reviewed.

8. ama-assn.org ama-assn.org/public-health/chronic-diseases/what-doctors-wish-patients-knew-about-rebound-congestion

What doctors wish patients knew about rebound congestion Nasal sprays decrease congestion · Longer use leads to rebound congestion · Only your nasal passages are affected · Rebound congestion is not a ...