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. 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
Must have symptoms of OSA prior to Inspire implantation
AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
Age 18 or above

Exclusion criteria

Significant central sleep apnea
Presence of other sleep disorders
History of neurologic or neuromuscular disease
Historical or present substance abuse
Bleeding disorders
Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
Pregnancy

Treatment and study plan

Awake endoscopy

Diagnostic Test

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.

Primary outcomes

Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jun 18, 2019
Registry last updated: Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed