| NCT ID | NCT04457154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inspire Medical Systems, Inc. |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-11-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-11-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04457154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 21 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04457154 currently recruiting?
Yes, NCT04457154 is actively recruiting participants. Contact the research team at gwengimmestad@inspiresleep.com for enrollment information.
Where is the NCT04457154 trial being conducted?
This trial is being conducted at Aurora, United States, Atlanta, United States, Durham, United States, Cincinnati, United States and 4 additional locations.
Who is sponsoring the NCT04457154 clinical trial?
NCT04457154 is sponsored by Inspire Medical Systems, Inc.. The trial plans to enroll 60 participants.