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Neurostimulation Device

Hypoglossal Nerve Stimulation for Down Syndrome

Phase 3
Recruiting
Led By Christopher Hartnick, MD
Research Sponsored by Inspire Medical Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 10-21 years
Severe OSA (AHI > 10, AHI < 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment
Must not have
Any contraindication for general anesthesia
Subject is currently taking muscle relaxant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months post-implant
Awards & highlights

Summary

This trial will follow 57 adolescents and young adults with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after they receive an implant of the Inspire Upper Airway Stimulation (UAS) System. The goal is to see if there is objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

Who is the study for?
Adolescents and young adults aged 10-21 with Down syndrome and moderate to severe sleep apnea, post-adenotonsillectomy. They must be English-speaking, able to communicate discomfort, willing to have a permanent implant and follow-up visits. Excluded are those needing future MRI of the chest, nonverbal individuals, BMI above the 95th percentile for age, certain medical conditions or medications that increase surgery risks.
What is being tested?
The trial is testing the Inspire Upper Airway Stimulation System in participants with Down syndrome and obstructive sleep apnea. It's a single-arm study where all enrolled will receive an implant and their cognition and language skills will be monitored over a year.
What are the potential side effects?
Potential side effects may include discomfort from having a device implanted permanently, possible pain or irritation at the implant site, risk associated with general anesthesia during surgery for device placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 21 years old.
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I have severe sleep apnea diagnosed by a sleep study after adenotonsillectomy.
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My child and I agree to a permanent implant and follow-up visits.
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I have been diagnosed with Down syndrome.
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I have had my adenoids and tonsils removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have general anesthesia due to health reasons.
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I am currently taking medication to relax my muscles.
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My throat collapses when I sleep, as seen in a sleep study.
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I do not have any health conditions causing instability like heart failure or severe lung disease.
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I need future MRI scans of my chest due to another health condition.
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My BMI is above the 95th percentile for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in attention using the Wechsler Intelligence Scale
Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)
Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)
+3 more
Secondary study objectives
Sleep Apnea, Obstructive
Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires
Rate of procedure and device-related adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects implanted with Inspire UAS SystemExperimental Treatment1 Intervention
Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.

Find a Location

Who is running the clinical trial?

Inspire Medical Systems, Inc.Lead Sponsor
12 Previous Clinical Trials
6,675 Total Patients Enrolled
1 Trials studying Down Syndrome
42 Patients Enrolled for Down Syndrome
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
348 Previous Clinical Trials
180,524 Total Patients Enrolled
3 Trials studying Down Syndrome
148 Patients Enrolled for Down Syndrome
National Institutes of Health (NIH)NIH
2,767 Previous Clinical Trials
8,133,798 Total Patients Enrolled
9 Trials studying Down Syndrome
1,760 Patients Enrolled for Down Syndrome
~0 spots leftby Sep 2024
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