N/A N=16 Other

Prospective Use of Awake Endoscopy for Inspire Activation

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT03990298 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects — 7; 3; 3; 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Awake endoscopy (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects	7; 3; 3; 2; 1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03990298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.