Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor

NCT ID: NCT04921800

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2024-09-02

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.

Detailed Description

Dysphagia, dysphonia, and loss of cervical range of motion (ROM) are common complications after anterior cervical spine surgery, specifically anterior cervical discectomy and fusion (ACDF). Despite their clinical importance, studies on the treatment and/or prevention of these complications are limited due to the lack of valid and reliable outcome measures. The majority of research is found in the otolaryngology literature and has focused on disease pathophysiology, diagnosis, and therapy.

Dysphagia and dysphonia are widely measured by patient self-reported questionnaires, including the MD Anderson Dysphasia Inventory and SWAL-QOL. However, these validated outcome tools are cumbersome to complete and, therefore, have not been widely accepted into clinical practice, including in postoperative ACDF patients. The Bazaz score, a subjective questionnaire that has not been validated in the literature, has also been used to evaluate dysphagia after ACDF. Assessment using the Bazaz score is based on clinical examination, with the surgeon listening to the patient's voice and documenting hoarseness in the post-operative period. Recently, new patient-centered outcomes, the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have been developed. Both EAT-10 and VHI-10 have excellent validity and reliability in evaluating dysphagia and dysphonia, respectively, in post-operative ACDF patients and can be used to document the initial dysphagia or dysphonia severity and monitor the treatment response in people with a wide array of swallowing and voice disorders. However, these methods of evaluating dysphagia and dysphonia alone offer limited information about the severity and characteristic of dysphagia or dysphonia and do not provide continuous monitoring of swallowing or speaking function throughout the post-operative period.

The wearable sensors under investigation in this study offer a novel, noninvasive, and easy-to-use way to monitor dysphagia, dysphonia, cervical ROM, and overall recovery progress in post-operative ACDF patients. Previous testing has demonstrated the ability of our sensors to monitor vital signs (including heart rate and respiratory rate), swallow count, talking time, energy expenditure, cervical neck movement, and body orientation. Sensor-measured swallow count and talking time, in conjunction with EAT-10 and VHI-10 scores, can provide a comprehensive view of the progression of dysphagia and dysphonia. Cervical neck movements measured by the sensor can enable continuous assessment of cervical ROM. Other general metrics captured by the sensors, including heart rate, respiratory rate, energy expenditure, and body orientation can provide other meaningful measures of recovery in post-operative ACDF patients. These sensors have also received positive feedback from patients and physicians on their comfort, ease of use, and application, further demonstrating the potential value of these sensors in improving the quality of post-operative care for ACDF patients.

Conditions

Cervical Spine Fusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Wearable Sensor Applied

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

Group Type: EXPERIMENTAL

Anterior Cervical Discectomy & Fusion

Intervention Type: PROCEDURE

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

Application of ADAM mechanoacoustic skin sensor

Intervention Type: DEVICE

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

Interventions

Anterior Cervical Discectomy & Fusion

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

Intervention Type: PROCEDURE

Application of ADAM mechanoacoustic skin sensor

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuai Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00213413

Identifier Type: -

Identifier Source: org_study_id