Wearable Sensor Monitoring for Cervical Spine Fusion Recovery

Palo Alto (17 mi)

Overseen byShuai Xu, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 18 to 88 who have had ACDF surgery for cervical radiculopathy or myelopathy and are scheduled for a post-op clinic visit. It excludes those with revised ACDF, surgeries due to trauma or cancer, and vulnerable groups like prisoners or pregnant women.

Inclusion Criteria

I am between 18 and 88 years old.

I had surgery to remove a disc in my neck due to nerve or spinal cord issues.

Exclusion Criteria

I have had surgery due to cancer or an injury.

I had a revision surgery for my previous neck fusion surgery.

Treatment Details

The study tests a new wearable skin sensor called ADAM mechanoacoustic sensor on patients after ACDF surgery. It aims to wirelessly monitor recovery by measuring heart rate, breathing rate, swallowing frequency, talking time, energy use, neck motion, and body position.

1Treatment groups

Experimental Treatment

Group I: Wearable Sensor AppliedExperimental Treatment2 Interventions

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