Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes

Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes

The purpose of this study is to use computers to simulate airflow in 3D construction of your nasal cavity generated from cone beam CT images. The results from computer simulations will help researchers identify the severity of cleft-induced nasal dysfunction and assess the impact of current treatment in restoring breathing function. The ultimate goal is to improve post-surgery outcomes to restore nasal breathing function to normal levels.

Study Overview

• Status: Recruiting
• Conditions: Nasal Obstruction; Cleft Lip and Nose
• Intervention / Treatment: Procedure: Surgical repair for nasal obstruction

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Amy Walker; Phone Number: 919-684-17325; Email: amy.walker1@duke.edu
• Study Contact Backup: Name: Victoria Johnson; Email: victoria.a.johnson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center and affiliated practices
      • Contact: Amy Walker; Phone Number: 919-684-1732; Email: AMY.WALKER1@DUKE.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral cleft lip nasal deformity scheduled to undergo elective surgery for nasal obstruction at the Duke Cleft and Craniofacial Center.

Existing CBCT imaging data and QOL measures previously collected on healthy subjects will be used for comparison. Healthy subjects will not be prospectively enrolled in the study.

Description

Inclusion Criteria:

• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Male or female, aged ≥18 years of age.
• Clinical diagnosis of unilateral cleft lip nasal deformity (uCLND)
• Scheduled to undergo elective surgery for nasal obstruction
• Scheduled to have a Cone Beam Computed Tomography (CBCT) as part of the pre- operative work-up for elective surgery.

Exclusion Criteria:

• Prior cleft rhinoplasty or septoplasty for correction of nasal obstruction
• Pregnant women: A pregnancy test will be performed within 48 hours of baseline
• Patients unable or unwilling to comply with study procedures outlined in protocol

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unilateral Cleft Lip Nasal Deformity (uCLND); uCLND patients who are scheduled to undergo surgical treatment for nasal obstruction as standard of care.	Procedure: Surgical repair for nasal obstruction; Patient reported quality of life questionnaires; Other Names: observational, patient reported outcome measures
Healthy Subjects; Existing data from healthy subjects with no prior symptoms of nasal obstruction used to create normative ranges for comparison to uCLND cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of computational fluid dynamics simulation with breathing measurement	Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement	6 months
Validation of computational fluid dynamics simulation with in vitro experiment	Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica	6 months
Effectiveness of current surgery in restoring nasal function based on volumetric airflow	Analysis of significant difference in volumetric airflow rate between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.	6 months
Effectiveness of current surgery in restoring nasal function based on nasal resistance	Analysis of significant difference in nasal resistance between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images	6 months
Effectiveness of current surgery in restoring nasal function based on nasal heat flux	Analysis of significant difference in nasal heat flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.	6 months
Effectiveness of current surgery in restoring nasal function based on nasal moisture flux	Analysis of significant difference in nasal moisture flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.	6 months
Anatomical sites of greatest nasal obstruction	Analysis on agreement of computational fluid dynamics identified anatomical sites of greatest nasal obstruction from pre-surgery 3D nasal models and actual surgical anatomical sites. CFD identified sites of greatest nasal obstruction are regions in the airway with highest nasal resistance.	6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow	Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computational fluid dynamics generated unilateral left and right side percent asymmetric will be computed used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients	6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance	Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal resistance will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients	6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux	Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal moisture flux will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by NOSE questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by SCHNOS questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by CLEFT-Q questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure	in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral airflow pressure.	6 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow	in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral volumetric airflow rate.	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Dennis Frank-Ito, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Congenital Abnormalities; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nose Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Respiratory Insufficiency; Airway Obstruction; Cleft Lip; Nasal Obstruction
• Other Study ID Numbers: Pro00102005; R01DE028554 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No