Clinical trial NCT04150783: Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes
Official title: Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cleft Lip and Nose
Nasal Obstruction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2019-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Validation of computational fluid dynamics simulation with breathing measurement
timeFrame: 6 months
measure: Validation of computational fluid dynamics simulation with in vitro experiment
timeFrame: 6 months
measure: Effectiveness of current surgery in restoring nasal function based on volumetric airflow
timeFrame: 6 months
measure: Effectiveness of current surgery in restoring nasal function based on nasal resistance
timeFrame: 6 months
measure: Effectiveness of current surgery in restoring nasal function based on nasal heat flux
timeFrame: 6 months
measure: Effectiveness of current surgery in restoring nasal function based on nasal moisture flux
timeFrame: 6 months
measure: Anatomical sites of greatest nasal obstruction
timeFrame: 6 months
measure: Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow
timeFrame: 6 months
measure: Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance
timeFrame: 6 months
measure: Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux
timeFrame: 6 months
Secondary outcomes:
measure: Change in patient-reported outcome (PRO) measures
timeFrame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
measure: Change in patient-reported outcome (PRO) measures
timeFrame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
measure: Change in patient-reported outcome (PRO) measures
timeFrame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
measure: in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure
timeFrame: 6 months
measure: in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center and affiliated practices
state: North Carolina
Study officials:
affiliation: Duke University
name: Dennis Frank-Ito, PhD
role: PRINCIPAL_INVESTIGATOR
References: