NCT06637774

The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

The Aspirometer: A Noninvasive Tool for Detecting Aspiration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This investigation evaluates the effectiveness of a device called the Aspirometer, which uses high resolution cervical auscultation (HRCA), in detecting when food or liquids enter the airway (aspiration) of the person swallowing, whether the person swallowing shows signs of aspiration (coughing) or not.

Detailed description

This aim of the project seeks to discriminate normal from abnormal airway protection and kinematic functions noninvasively via machine-learning analysis of Aspirometer/HRCA (high resolution cervical auscultation) signals, with similar accuracy as human judgment of VF. Hypothesis: Advanced data analytics can detect pathological airway protection in HRCA signal signatures with 90% accuracy when compared to a human expert's airway protection ratings from VF images. Analytical algorithms that can learn from data (e.g., Bayes' learning) will be used to infer about the continuum of abnormal airway protection during swallowing.

Conditions

• Deglutition Disorders

Interventions

Type	Name	Description
DEVICE	Aspirometer	a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively
DEVICE	Videofluoroscopic X-ray	MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2024-10-15
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

1 site across 1 country: United States