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

NCT04150783 | Completed

• 2 other identifiers: Pro00102005R01DE028554
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Lip and Nose; Nasal Obstruction

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Change in patient-reported outcome (PRO) measures

  baseline, 2 weeks, 8 weeks, 6 months, 12 months

• Change in patient-reported outcome (PRO) measures

  baseline, 2 weeks, 8 weeks, 6 months, 12 months

• Change in patient-reported outcome (PRO) measures

  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

  6 months

• in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow

  6 months

Study Arms (2)

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

Healthy Subjects

Existing data from healthy subjects with no prior symptoms of nasal obstruction used to create normative ranges for comparison to uCLND cohort.

Interventions

Surgical repair for nasal obstruction PROCEDURE

Patient reported quality of life questionnaires

Also known as: observational, patient reported outcome measures

Unilateral Cleft Lip Nasal Deformity (uCLND)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Russel SM, Chiang H, Finlay JB, Shah R, Marcus JR, Jang DW, Abi Hachem R, Goldstein BJ, Frank-Ito DO. Characterizing Olfactory Dysfunction in Patients with Unilateral Cleft Lip Nasal Deformities. Facial Plast Surg Aesthet Med. 2023 Nov-Dec;25(6):457-465. doi: 10.1089/fpsam.2022.0367. Epub 2023 May 2.

  PMID: 37130297 DERIVED

MeSH Terms

Conditions

Cleft Lip; Nasal Obstruction

Interventions

Wound Healing; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Dennis Frank-Ito, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: January 31, 2025
• Study Completion: July 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)