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NCT03990298 · ClinicalTrials.gov registry record · NA
Prospective Use of Awake Endoscopy for Inspire Activation
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03990298: Completed NA study, sponsored by University of Pennsylvania.
NCT03990298 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03990298, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Awake endoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2020-06-09 |
| Phase | NA |
What the finished NCT03990298 record still lists
NCT03990298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Awake endoscopy is the first listed.
NCT03990298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03990298 about?
NCT03990298 is a clinical study titled "Prospective Use of Awake Endoscopy for Inspire Activation". The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. Th...
What is the current status of trial NCT03990298?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-11-01. Estimated completion is 2020-06-09.
What interventions are being tested in trial NCT03990298?
The interventions under investigation include: Awake endoscopy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03990298?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03990298's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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