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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months post-implant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
11 Previous Clinical Trials
6,630 Total Patients Enrolled
1 Trials studying Down Syndrome
42 Patients Enrolled for Down Syndrome
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,414 Total Patients Enrolled
2 Trials studying Down Syndrome
90 Patients Enrolled for Down Syndrome
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,819 Total Patients Enrolled
9 Trials studying Down Syndrome
1,760 Patients Enrolled for Down Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing recruitment efforts for this research endeavor?

"Affirmative. According to the clinical research posted on clinicaltrials.gov, this trial is actively seeking enrolment and commenced recruitment efforts on June 24th 2021. The study requires 68 participants from 6 different medical centres."

Answered by AI

How widespread is the implementation of this experiment?

"This study is actively recruiting from 6 different locations, such as the University of Texas Southwestern/Children's Hospital of Dallas in Dallas, Massachusetts General Hospital (Mass Eye & Ear Infirmary) in Boston and Children's Healthcare of Atlanta/ Emory University School of Medicine in Atlanta. Additionally, there are 3 other sites participating."

Answered by AI

What is the total sample size of this research endeavor?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, which initiated on June 24th 2021 is currently recruiting patients. There are 6 medical sites aiming to recruit a total of 68 participants for the study."

Answered by AI

Has the Inspire UAS System been sanctioned by the FDA?

"Our team at Power gave Inspire Upper Airway Stimulation (UAS) System a score of 2 due to its Phase 2 status, which suggests that there is evidence confirming safety but no proof of efficacy."

Answered by AI

Does this research protocol permit participation of septuagenarians?

"According to the criteria, 10 is the lowest age for enrolment and 21 is the uppermost limit."

Answered by AI

What criteria must be met to qualify for participation in this trial?

"This trial seeks to enrol 68 individuals with Down syndrome aged between 10 and 21. To qualify, candidates must satisfy the following conditions: Age range of 10-21 years old; consent from both children and their guardians regarding implantation of stimulation hardware as well as follow up visits, postoperative PSG and questionnaire completion; confirmation that they are able to detect any adverse effects related to device insertion in the child; either a tracheotomy or an ineffective treatment with CPAP due to lack of compliance, discomfort, undesirable side effects, persistent symptoms despite usage or refusal for use respectively."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Maryland
How old are they?
18 - 65
What site did they apply to?
University of Texas Southwestern/Children's Hospital of Dallas
Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
2021. "Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04801771.
All > Apnea > Down Syndrome
~7 spots leftby Sep 2024
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