An interventional study of Anterior Cervical Discectomy & Fusion and Application of ADAM mechanoacoustic skin sensor in Cervical Spine Fusion, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Northwestern University · Not applicable, Interventional, and Other
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.
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants are undergoing previously scheduled anterior cervical discectomy \& fusion for single level or multiple level cervical disease
Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data
Vibrational Frequency of Vocalization Following Surgery
Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge
| Milestone | Wearable Sensor Applied |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)
No measurements were reported for this outcome.
Sensitivity of the device to temperature of the surgical site in degrees Celsius
No measurements were reported for this outcome.
Force vectors measured in gravitational acceleration units (g; 9.81 meters per second squared)
No measurements were reported for this outcome.
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
| percentage of correct motions detected | Wearable Sensor Applied |
|---|---|
| Algorithm Validation | 67.5 ± 5.8 |
Collected over 2 weeks postoperative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wearable Sensor Applied | 0/11 (0%) | 0/11 (0%) | 5/11 (45.5%) |
| Event | Wearable Sensor Applied |
|---|---|
| PainMusculoskeletal and connective tissue disorders | 5/11 |
| Age, Continuous(years) | Wearable Sensor Applied |
|---|---|
| Mean | 57 ± 11 |
| Sex: Female, Male(Participants) | Wearable Sensor Applied |
|---|---|
| Female | 7 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Wearable Sensor Applied |
|---|
| Region of Enrollment(participants) | Wearable Sensor Applied |
|---|---|
| United States | 11 |
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