Recruiting

Nasal Irrigation

Sponsor:

Ohio State University

Code:

NCT06118554

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis Without Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Irrigation head position

Study Details

Brief summary:

Three-dimensional (3D) printing has been an emerging technology with uses in a wide array of fields. This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's individual anatomy. With increased irrigation to the sinuses, we hypothesize there will be improved patient satisfaction and higher quality of life. The outcomes of this research could lead to a new option for patients who live with chronic rhinosinusitis are not candidates for surgery or are interested in less invasive options. The 3D printed nasal replica is not something that would be implanted, rather it is a hand-held device used specifically for participants to better understand their nasal anatomy.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis Without Nasal Polyps

Study ID

NCT06118554

Start date

Nov 1, 2021

Status verified date

May, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).

Exclusion Criteria:

  • Patients with significant nasal polyps (as determined by a clinician) were excluded upfront due to the unlikeness of irrigation penetration regardless of the head position. Patients with significant atopy, cystic fibrosis, granulomatosis with polyangiitis or other connective tissue disorder, and current pregnancy were also excluded.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control group

The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.

experimental: Backfill group

Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.

experimental: Model group

Finally, the model group (MG) irrigated in an optimal position based on their 3D nasal replica. This patient-specific position was communicated to each MG patient with clear instructions during an in-person training session.

Interventions

Irrigation head position

Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The only factor that varied between groups was the head position patients irrigated in.

Primary outcome measure

  • Nasal Obstruction Symptom Evaluation (NOSE) score [ Time Frame: completed at baseline and after 8 weeks of treatment. ]
  • 22-item Sino-Nasal Outcome Test (SNOT-22) score [ Time Frame: completed at baseline and after 8 weeks of treatment. ]
  • Visual Analogue Scale (VAS) of nasal congestion score [ Time Frame: completed at baseline and after 8 weeks of treatment. ]
  • Lund-Mackay (LM) score of sinus inflammation. [ Time Frame: assessed from CT scans taken at baseline and after 8 weeks of treatment. ]

Central Contacts and Locations

Central contacts

Kai Zhao, PhD

2673032322zhao.1949@osu.edu

Zachary T. Root, BS

6145609257zachary.root@osumc.edu

Locations

The Ohio State University Eye and Ear Institue

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Kai Zhao, PhD

2673032322zhao.1949@osu.edu

Principal Investigator:

Kai Zhao, PhD

More Information

Sponsor

Ohio State University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • 3D modeling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-26.