Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor

NCT04921800 | Completed Results FDA Device

• 1 other identifier: STU00213413
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervical spine; fusion; discectomy; wearable technology

Outcome Measures

Primary Outcomes (4)

• Vibrational Frequency of Vocalization Following Surgery

  Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)

  0 to 24 hours post operative

• Skin Temperature of the Surgical Site

  Sensitivity of the device to temperature of the surgical site in degrees Celsius

  0 to 24 hours post operative

• Muscular Force Generated During Range of Motion Exercises

  Force vectors measured in gravitational acceleration units (g; 9.81 meters per second squared)

  0 to 24 hours post operative

• Algorithm Validation

  Measuring the accuracy of the algorithm created to measure neck motion using the ADvanced Acousto-Mechanic sensor. Data analysis made no distinction between motion samples collected immediately after awaking from sedation in the post-anesthesia care unit and those collected immediately prior to discharge

  Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge

Study Arms (1)

Wearable Sensor Applied

EXPERIMENTAL

For these participants, the wearable ADAM sensor will be placed in the sternal notch to record anatomical data during the post-surgical period for up to 14 days

Procedure: Anterior Cervical Discectomy & Fusion; Device: Application of ADAM mechanoacoustic skin sensor

Interventions

Anterior Cervical Discectomy & Fusion PROCEDURE

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

Wearable Sensor Applied

Application of ADAM mechanoacoustic skin sensor DEVICE

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

Wearable Sensor Applied

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone anterior cervical discectomy and fusion (ACDF) for one or more levels for a diagnosis of cervical radiculopathy or myelopathy
• Scheduled to return to the MSK orthopaedic clinic for a post-operative appointment
• Aged between 18 to 88 years at time of surgery

You may not qualify if:

• Patients that underwent a revision of previous ACDF surgery at one or more operative levels
• Surgeries performed for a traumatic or oncologic etiology
• Members of vulnerable populations (i.e. prisoners, pregnant women)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Klippel-Feil Syndrome

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Limitations and Caveats

The data collected by investigators did not match the a priori variables defined.

Results Point of Contact

• Title: Shuai Xu
• Organization: Northwestern University

stevexu@northwestern.edu

312-695-3721

Study Officials

• Shuai Xu, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients enrolled in the study \& scheduled for surgical intervention with anterior cervical discectomy and fusion will have the superficial sensor applied to the suprasternal notch following closure of the surgical incision. The data collected by the sensor will be recorded via a remote application and the sensor will then be removed 24 hours following placement. All patients enrolled in the study will be affixed with an identical sensor in accordance with the procedure outlined in the study protocol.

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: June 10, 2021
• Study Start: March 15, 2021
• Primary Completion: December 23, 2021
• Study Completion: September 2, 2024
• Last Updated: May 9, 2025
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (1)