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Completed

NCT Number: NCT04150783

Computational Modeling of Cleft Lip Nasal Deformity and Assessment of 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical repair for nasal obstruction

Procedure

Patient reported quality of life questionnaires

Other names: observational, patient reported outcome measures

Primary outcomes

  1. Validation of computational fluid dynamics simulation with breathing measurement

    Time frame: 6 months

    Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement

  2. Validation of computational fluid dynamics simulation with in vitro experiment

    Time frame: 6 months

    Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica

  3. Effectiveness of current surgery in restoring nasal function based on volumetric airflow

    Time frame: 6 months

    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.

  4. Effectiveness of current surgery in restoring nasal function based on nasal resistance

    Time frame: 6 months

    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

  5. Effectiveness of current surgery in restoring nasal function based on nasal heat flux

    Time frame: 6 months

    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. Effectiveness of current surgery in restoring nasal function based on nasal moisture flux

    Time frame: 6 months

    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.

  7. Anatomical sites of greatest nasal obstruction

    Time frame: 6 months

    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.

  8. Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow

    Time frame: 6 months

    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

  9. Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance

    Time frame: 6 months

    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

  10. Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux

    Time frame: 6 months

    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

Secondary outcomes

  1. Change in patient-reported outcome (PRO) measures

    Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months

    Change PRO measures as measured by NOSE questionnaire

  2. Change in patient-reported outcome (PRO) measures

    Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months

    Change PRO measures as measured by SCHNOS questionnaire

  3. Change in patient-reported outcome (PRO) measures

    Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months

    Change PRO measures as measured by CLEFT-Q questionnaire

  4. in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2019
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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