Registry for young patients with obstructive sleep apnea receiving Inspire therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry is a prospective, multi-center, single-arm study focusing on pediatric patients aged 18 to 21 years who are undergoing implantation of the Inspire Upper Airway Stimulation (UAS) System to treat moderate to severe obstructive sleep apnea (OSA). Participants will be monitored for safety and effectiveness over a five-year period, with data collected at various time points including pre-implant, one month post-implant, and annually for five years. The study aims to gather comprehensive data from at least 60 subjects across multiple clinical centers in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is between 18 and 21 years of age;
2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
7. 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 registry;
8. Subject is willing and able to provide informed consent.

Exclusion Criteria:

1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
2. 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;
3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
5. Subject is pregnant or plans to become pregnant;
6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
7. Subject has a terminal illness with life expectancy \< 12 months;
8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Where it's running

• Childrens Hospital of Colorado
  Aurora, Colorado, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Cincinnati Childrens Hospital
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Children's Hospital of Pittsburgh
  Sewickley, Pennsylvania, United States Recruiting
• University of Texas Southwestern/Children's Hospital of Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Gwen Gimmestad
• Email: gwengimmestad@inspiresleep.com
• Phone: 763-392-9966

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.