A New Treatment for Mechanical Nasal Obstruction

NCT03456115 | Completed Results FDA Device

• 1 other identifier: IRB00135539
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The research team has developed a prototype for an investigational mechanical nasal dilator and the investigators aim to evaluate its efficacy. Specifically, the investigators wish to address the following research questions: 1) How does mechanical nasal obstruction affect patients' lives? The investigators aim to answer this question with use of validated questionnaires. 2) How do currently available mechanical nasal dilators affect objective and subjective findings related to nasal obstruction? This will be evaluated with objective nasal airflow testing and with modifications to validated questionnaires 3) How does the investigational team's novel device affect these same outcome measures? 4) Do patients find the investigational device subjectively comfortable and efficient?

Conditions

Nasal Obstruction

Keywords

nasal obstruction; nasal valve collapse

Outcome Measures

Primary Outcomes (1)

• Change in Peak Nasal Inspiratory Flow (PNIF)

  PNIF will be measured using a PNIF meter. PNIF will be measured without any device in place and once during the fitting of each device. Flow is measured in liters per minute. Minimum value of -50, maximum value of 150 with higher scores indicating improved airflow.

  Prior to device and after fitting each device (Up to 5 minutes)

Secondary Outcomes (3)

• Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE)

  Baseline

• Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE)

  24-hour after trial of each device

• Device Preference

  Up to 5 days

Study Arms (1)

Mechanical Nasal Dilator

EXPERIMENTAL

All participants will be trialing the 5 devices and reporting their thoughts on comfort, and perception of symptoms of mechanical nasal obstruction by way of survey completion. The devices include 4 commercially available nasal dilators: Breathe Right, Max Air, Sleep Right, Nozovent, and the study team's investigational device dubbed the Schnozzle.

Device: Mechanical nasal dilator

Interventions

Mechanical nasal dilator DEVICE

Participants will be asked to trial 5 different mechanical nasal dilators. 4 of which are commercially available and one of which is the investigational device being studied for feasibility. The 4 commercially available nasal dilators include Breathe Right, Max Air, Sleep Right, Nozovent. The fifth device is the study team's investigational device dubbed the Schnozzle.

Mechanical Nasal Dilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have presented to Otolaryngology clinics with complaints of nasal obstruction.
• Patients who have been found to have nasal valve collapse by an Otolaryngologist based on performance of the Cottle maneuver will be invited to participate in the study.
• Patients without evidence of nasal valve collapse, but are willing to participate in the study.

You may not qualify if:

• History of granulomatosis with polyangiitis, extensive prior sinus or turbinate surgery altering nasal cavity anatomy, pre-existing nasal mucosal injuries or abnormalities

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Related Publications (10)

• Jessen M, Malm L. Definition, prevalence and development of nasal obstruction. Allergy. 1997;52(40 Suppl):3-6. doi: 10.1111/j.1398-9995.1997.tb04876.x. No abstract available.

  PMID: 9353553 BACKGROUND

• Bloching MB. Disorders of the nasal valve area. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2007;6:Doc07. Epub 2008 Mar 14.

  PMID: 22073083 BACKGROUND

• Miman MC, Deliktas H, Ozturan O, Toplu Y, Akarcay M. Internal nasal valve: revisited with objective facts. Otolaryngol Head Neck Surg. 2006 Jan;134(1):41-7. doi: 10.1016/j.otohns.2005.08.027.

  PMID: 16399179 BACKGROUND

• Camacho M, Zaghi S, Certal V, Abdullatif J, Modi R, Sridhara S, Tolisano AM, Chang ET, Cable BB, Capasso R. Predictors of Nasal Obstruction: Quantification and Assessment Using Multiple Grading Scales. Plast Surg Int. 2016;2016:6945297. doi: 10.1155/2016/6945297. Epub 2016 May 16.

  PMID: 27293885 BACKGROUND

• Khosh MM, Jen A, Honrado C, Pearlman SJ. Nasal valve reconstruction: experience in 53 consecutive patients. Arch Facial Plast Surg. 2004 May-Jun;6(3):167-71. doi: 10.1001/archfaci.6.3.167.

  PMID: 15148124 BACKGROUND

• Kiyohara N, Badger C, Tjoa T, Wong B. A Comparison of Over-the-Counter Mechanical Nasal Dilators: A Systematic Review. JAMA Facial Plast Surg. 2016 Sep 1;18(5):385-9. doi: 10.1001/jamafacial.2016.0291.

  PMID: 27367589 BACKGROUND

• Picavet VA, Grietens J, Jorissen M, Hellings PW. Rhinoplasty from a rhinologist's perspective: need for recognition of associated sinonasal conditions. Am J Rhinol Allergy. 2012 Nov-Dec;26(6):493-6. doi: 10.2500/ajra.2012.26.3816.

  PMID: 23232202 BACKGROUND

• Samaha M, Rassouli A. Spreader graft placement in endonasal rhinoplasty: Technique and a review of 100 cases. Plast Surg (Oakv). 2015 Winter;23(4):252-4. doi: 10.4172/plastic-surgery.1000944.

  PMID: 26665141 BACKGROUND

• Kimbell JS, Frank-Ito DO. Mechanical Nasal Dilators for the Management of Nasal Obstruction. JAMA Facial Plast Surg. 2016 Sep 1;18(5):389-90. doi: 10.1001/jamafacial.2016.0656. No abstract available.

  PMID: 27367256 BACKGROUND

• Raudenbush B. Stenting the nasal airway for maximizing inspiratory airflow: internal Max-Air Nose Cones versus external Breathe Right strip. Am J Rhinol Allergy. 2011 Jul-Aug;25(4):249-51. doi: 10.2500/ajra.2011.25.3621.

  PMID: 21819762 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Christopher Razavi, MD
• Organization: Johns Hopkins University Hospital

crazavi1@jhmi.edu

410-955-2307

Study Officials

• Nicholas Rowan

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be unaware of which nasal dilator they are trialing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo the same intervention, which is a trial of various internal nasal dilators.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 7, 2018
• Study Start: October 1, 2018
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)