Orange, CANCT06851338Now EnrollingIRB Ready

Pediatric Obstructive Sleep Apnea Clinical Trial in Orange, CA

Access cutting-edge pediatric obstructive sleep apnea treatment through this clinical trial at a research site in Orange. Study-provided care at no cost to qualified participants.

Sponsored by Inspire Medical Systems, Inc.

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Expert Care in Orange

Access pediatric obstructive sleep apnea specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pediatric obstructive sleep apnea treatment provided free

Apply for This Orange Location

Check if you qualify for this pediatric obstructive sleep apnea clinical trial in Orange, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Orange

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orange site if eligible
  4. 4Begin participation

About This Pediatric Obstructive Sleep Apnea Study in Orange

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Sponsor: Inspire Medical Systems, Inc.

Who Can Participate

Inclusion Criteria

Patient has been diagnosed with Down syndrome;
Patient is 13-18 years of age;
Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.

Exclusion Criteria

Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
Patient 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;
Patient has any condition or procedure that has compromised neurological control of the upper airway;
Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
Patient is pregnant or plans to become pregnant;
Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
Patient has a terminal illness with life expectancy of less than 12 months;
Any other reason the investigator deems the patient is unfit for participation in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orange?

Yes, this clinical trial (NCT06851338) has an active research site in Orange, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pediatric Obstructive Sleep Apnea Treatment Options in Orange, CA

If you're searching for pediatric obstructive sleep apnea treatment options in Orange, CA, this clinical trial (NCT06851338) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orange research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pediatric obstructive sleep apnea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pediatric obstructive sleep apnea clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Orange, CA