Inspire Upper Airway Stimulation System for Obstructive Sleep Apnea: Post Approval Study

Inspire Upper Airway Stimulation System for Obstructive Sleep Apnea: Post Approval Study
Recruiting
22 years - 100 years
All
Phase 4
10 participants needed
1 Location

Brief description of study

Patients with Obstructive Sleep Apnea (OSA) who are interested in pursuing surgical treatment may be candidates for the Inspire device, an FDA-approved upper airway stimulation device that can help to treat OSA. This trial is collecting long-term safety and efficacy data in participants that are implanted with the Inspire device.

Detailed description of study

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy. The study will be conducted in a post-market environment for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (20≤AHI≤65) in subjects who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments. Subjects meeting all baseline and pre-screening requirements will be implanted with the Inspire system. The Inspire implant process is conducted clinically through the patient's insurance plan. One-hundred and twenty-seven (127) study subjects will be implanted at up to 20 investigational sites in the United States. Subjects will be evaluated at baseline, implant, 1-, 2-, 6- and 12- months post-implant, and bi-annually thereafter through 5 years of post-implant follow-up. Evaluations include questionnaires, medical history evaluation, and evaluation of effect of the Inspire treatment on the patient's sleep apnea. A single night in-lab Polysomnography (PSG) sleep study will be conducted at baseline, and at the 1 and 3 year follow ups. Two night home sleep testing (HST) will be conducted at the 2, 4, and 5 year follow ups. Compensation will be provided for time and travel for research visits.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Obstructive sleep apnea, Obstructive Sleep Apnea (OSA)
  • Age: 22 years - 100 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 822568

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Message For Non Enrolling By Invitation Trial

Select a study center that’s convenient for you, and get in touch with the study team.