Prospective Use of Awake Endoscopy for Inspire Activation

University of Pennsylvania

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Diagnostic Test: Awake endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03990298

828956

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

All subjects

Other group

Description:

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.

Treatment:

Diagnostic Test: Awake endoscopy