Registry for young patients with obstructive sleep apnea receiving Inspire therapy
Inspire Pediatric Post-Approval Registry
This study is looking at how well the Inspire therapy works for young adults aged 18 to 21 with moderate to severe obstructive sleep apnea over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 21 Years |
| Sex | All |
| Sponsor | Inspire Medical Systems, Inc. Industry-sponsored |
| Locations | 8 sites (Aurora, Colorado and 7 other locations) |
| Trial ID | NCT04457154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 21 with moderate to severe obstructive sleep apnea who have not responded to other treatments.
Not a fit: Patients with central or mixed apneas or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the Inspire UAS System in young patients with obstructive sleep apnea.
How similar studies have performed: While this registry approach is not novel, similar studies have shown success in evaluating the effectiveness of the Inspire therapy in adult populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aurora, Colorado and 7 other locations
- Childrens Hospital of Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Terminated)
- 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)
- Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Gwen Gimmestad
- Email: gwengimmestad@inspiresleep.com
- Phone: 763-392-9966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.