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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cervical Discectomy & Fusion | Procedure | Participants are undergoing previously scheduled anterior cervical discectomy & fusion for single level or multiple level cervical disease |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuai Xu, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Anterior Cervical Discectomy & Fusion: Participants are undergoing previously scheduled anterior cervical discectomy & fusion for single level or multiple level cervical disease Application of ADAM mechanoacoustic skin sensor: Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Anterior Cervical Discectomy & Fusion: Participants are undergoing previously scheduled anterior cervical discectomy & fusion for single level or multiple level cervical disease Application of ADAM mechanoacoustic skin sensor: Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vibrational Frequency of Vocalization Following Surgery | Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz) | Investigators did not collect this variable. | Posted | 0 to 24 hours post operative |
|
2 weeks postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Anterior Cervical Discectomy & Fusion: Participants are undergoing previously scheduled anterior cervical discectomy & fusion for single level or multiple level cervical disease Application of ADAM mechanoacoustic skin sensor: Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient was in too much pain to wear sensor and/or perform range of motion activities |
The data collected by investigators did not match the a priori variables defined.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuai Xu | Northwestern University | 312-695-3721 | stevexu@northwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2021 | Dec 1, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2021 | Dec 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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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.
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| 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 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Skin Temperature of the Surgical Site | Sensitivity of the device to temperature of the surgical site in degrees Celsius | Investigators did not collect this variable. | Posted | 0 to 24 hours post operative |
|
|
| Primary | Muscular Force Generated During Range of Motion Exercises | Force vectors measured in gravitational acceleration units (g; 9.81 meters per second squared) | Investigators did not collect this variable. | Posted | 0 to 24 hours post operative |
|
|
| Primary | 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 | patients | Posted | Mean | Standard Deviation | percentage of correct motions detected | Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
|
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| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |