Trial Outcomes & Findings for Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor (NCT NCT04921800)

Results Overview

Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

0 to 24 hours post operative

Results posted on

2025-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wearable Sensor Applied n=11 Participants 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
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=11 Participants
Sex: Female, Male Female	7 Participants n=11 Participants
Sex: Female, Male Male	4 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: 0 to 24 hours post operative

Population: Investigators did not collect this variable.

Sensitivity of the device to mechanoacoustic output from motion and vocalization in hertz (Hz)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0 to 24 hours post operative

Population: Investigators did not collect this variable.

Sensitivity of the device to temperature of the surgical site in degrees Celsius

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0 to 24 hours post operative

Population: Investigators did not collect this variable.

Force vectors measured in gravitational acceleration units (g; 9.81 meters per second squared)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge

Population: patients

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

Outcome measures

Outcome measures
Measure	Wearable Sensor Applied n=5 Participants 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
Algorithm Validation	67.5 percentage of correct motions detected Standard Deviation 5.8

Adverse Events

Wearable Sensor Applied

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Wearable Sensor Applied n=11 participants at risk 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
Musculoskeletal and connective tissue disorders Pain	45.5% 5/11 • Number of events 5 • 2 weeks postoperative

Additional Information

Shuai Xu

Northwestern University

Phone: 312-695-3721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place