Trial Outcomes & Findings for Prospective Use of Awake Endoscopy for Inspire Activation (NCT NCT03990298)

NCT ID: NCT03990298

Last Updated: 2021-08-04

Results Overview

The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either "Off," "Positive," or "Negative." For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: One month after surgical implantation of UAS
• Results posted on: 2021-08-04

Participant Flow

Participant milestones

Measure	Awake Endoscopic Exam Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. Awake endoscopy: Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Use of Awake Endoscopy for Inspire Activation

Baseline characteristics by cohort

Measure	Awake Endoscopic Examination n=16 Participants Subjects who underwent upper airway stimulation (UAS) implantation were recruited for a prospective single-arm cohort study during UAS device activation. Functional thresholds were recorded for all settings. Awake nasopharyngoscopy was performed to examine the retropalatal (RP) and retroglossal (RG) regions at rest and during activation at five different electrode configurations at their functional thresholds. Electrode configurations included: +-+, ---, -o-, o-o, and -+-. Cross-sectional measurements were made by two blinded reviewers and reported as percent change in airway size.
Age, Continuous	66.1 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after surgical implantation of UAS

The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either "Off," "Positive," or "Negative." For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation.

Outcome measures

Measure	Awake Endoscopic Exam n=16 Participants Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. Awake endoscopy: Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects Positive, Negative, Positive (+-+)	7 Participants
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects Negative, Negative, Negative (---)	3 Participants
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects Off, Negative, Off (o-o)	3 Participants
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects Negative, Off, Negative (-o-)	2 Participants
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects Negative, Positive, Negative (-+-)	1 Participants

Adverse Events

Awake Endoscopic Examination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erica Thaler, MD

Hospital of the University of Pennsylvania, Dept of Otorhinolaryngology, Head & Neck Surgery

Phone: 215-662-4533

Email: erica.thaler@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place