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Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor

NCT04921800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-05-09

Study results available
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Summary

The purpose of this study is to assess the function and reliability of a noninvasive, skin-like electronic sensor. The investigators hypothesize that this skin sensor will address an unmet need to wirelessly and noninvasively monitor and characterize the recovery process in post-operative patients who have undergone anterior cervical discectomy and fusion (ACDF). Specifically, the investigators will validate the use of the sensor in this patient population through monitoring of key physiological signals in the recovery process, including heart rate, respiratory rate, swallow count, talking time, energy expenditure, neck specific motion, and body orientation.

Conditions

  • Cervical Spine Fusion

Interventions

PROCEDURE

Anterior Cervical Discectomy & Fusion

Participants are undergoing previously scheduled anterior cervical discectomy \& fusion for single level or multiple level cervical disease

DEVICE

Application of ADAM mechanoacoustic skin sensor

Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data

Sponsors & Collaborators

Principal Investigators

  • Shuai Xu, MD · Northwestern University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2021-12-23
Completion
2024-09-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921800 on ClinicalTrials.gov