Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor

Not Applicable

Completed

Conditions: Cervical Spine Fusion

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

Registration Number: NCT04921800

Lead Sponsor: Northwestern University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearable Sensor Applied	Application of ADAM mechanoacoustic skin sensor	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
Wearable Sensor Applied	Anterior Cervical Discectomy & Fusion	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

Primary Outcome Measures

Name	Time	Method
Skin Temperature of the Surgical Site	0 to 24 hours post operative	Sensitivity of the device to temperature of the surgical site in degrees Celsius
Muscular Force Generated During Range of Motion Exercises	0 to 24 hours post operative	Force vectors measured in gravitational acceleration units (g; 9.81 meters per second squared)
Algorithm Validation	Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge	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
Vibrational Frequency of Vocalization Following Surgery	0 to 24 hours post operative	Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)