An observational study in Cleft Lip and Nose and Nasal Obstruction, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Duke University · Observational
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.
162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 45 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
uCLND patients who are scheduled to undergo surgical treatment for nasal obstruction as standard of care.
Procedure: Surgical repair for nasal obstruction
Existing data from healthy subjects with no prior symptoms of nasal obstruction used to create normative ranges for comparison to uCLND cohort.
Patient reported quality of life questionnaires
Also known as: observational, patient reported outcome measures
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Change in patient-reported outcome (PRO) measures
Change PRO measures as measured by NOSE questionnaire
Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures
Change PRO measures as measured by SCHNOS questionnaire
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Duke University