Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor (NCT04921800) | Clinical Trial Compass
CompletedNot Applicable
Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor
United States11 participantsStarted 2021-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 88 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vibrational Frequency of Vocalization Following Surgery
Timeframe: 0 to 24 hours post operative
2
Skin Temperature of the Surgical Site
Timeframe: 0 to 24 hours post operative
3
Muscular Force Generated During Range of Motion Exercises
Timeframe: 0 to 24 hours post operative
4
Algorithm Validation
Timeframe: Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge