Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inspire® UAS System.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Inspire UAS High AHI/High BMI Post-Approval Study
Overview
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
Detailed description
This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65\<AHI≤100 events/hr), as well as those with a higher BMI (32\<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
Interventions
- Device Inspire® UAS System
Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
Primary outcome measures
- Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) [Time frame: 5 years post-implant]
Secondary outcome measures (5)
- Change in Apnea Hypopnea Index Over Time [Time frame: 5 years post-implant]
- Body Mass Index [Time frame: 5 years post-implant]
- Change in Oxygen Desaturation Index (ODI) Over Time [Time frame: 5 years post-implant]
- Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time [Time frame: 5 years post-implant]
- Change in Epworth Sleepiness Scale (ESS) Over Time [Time frame: 5 years post-implant]
Eligibility criteria
Inclusion criteria
- Subject is at least 18 years of age;
- Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32<BMI≤40 kg/m2;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study;
- Subject is willing and able to provide informed consent.
Exclusion criteria
- Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);
- Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable or does not have the necessary assistance to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy < 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 5 centers
- Colorado ENT & Allergy — Colorado Springs
- Florida Sleep Specialists — Bradenton
- Rush University Medical Center — Chicago
- University of Kansas Medical Center — Kansas City
- University of Rochester — Rochester
Identifiers
NCT: NCT07113288 · 2023-005