Inspire Upper Airway Stimulation (UAS) System for Down Syndrome

Phase-Based Estimates
1
Effectiveness
2
Safety
Children's Hospital of Pittsburgh, Pittsburgh, PA
Down Syndrome+5 More
Inspire Upper Airway Stimulation (UAS) System - Device
Eligibility
< 65
All Sexes
Eligible conditions
Down Syndrome

Study Summary

This study is evaluating whether a device can improve cognition and language in people with Down syndrome.

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Eligible Conditions

  • Down Syndrome
  • Syndrome
  • Sleep Apnea Syndromes
  • Apnea
  • Sleep Apnea, Obstructive
  • Obstructive Sleep Apnea (OSA)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Inspire Upper Airway Stimulation (UAS) System will improve 6 primary outcomes and 3 secondary outcomes in patients with Down Syndrome. Measurement will happen over the course of 6 Months post-implant.

12 months post-implant
Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires
Month 12
Change in Obstructive Sleep Apnea (OSA)
6 Months post-implant
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)
Change in language using Expressive Language Sampling
Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning
Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Month 12
Rate of procedure and device-related adverse events

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Subjects implanted with Inspire UAS System

This trial requires 68 total participants across 2 different treatment groups

This trial involves 2 different treatments. Inspire Upper Airway Stimulation (UAS) System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Subjects implanted with Inspire UAS System
Device
Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 12 months post-implant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, 12 months post-implant for reporting.

Closest Location

Children's Hospital of Pittsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 10-21 years
Diagnosis of Down syndrome
Prior adenotonsillectomy
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
Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment
Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device
Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion
Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation
Children and their parents/guardians must be proficient in English

Patient Q&A Section

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

How many people get down syndrome a year in the United States?

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It is estimated that there were more than 140,000 patients with Down syndrome per year in the 1970s. In the 1990s, there were about 90,000 children diagnosed annually. This means that there have been about one new case of Down syndrome per year for most of the past 50 years.

Unverified Answer

What are the signs of down syndrome?

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Down Syndrome is a condition in which the child is born with certain characteristics or symptoms. The hallmark of Down Syndrome is a distinct facial appearance. Other signs or symptoms include a higher rate of mental retardation, intellectual disability, some type of learning disorder, and other symptoms and syndromes associated with this condition. The causes of Down Syndrome are not known. Down Syndrome usually results from a nondisjunction and in the majority of cases both parents carry a trisomy 21 chromosome. In the few cases where one parent does not carry a trisomy, the parent passes on genetic material of the disease to one of their children in every case. In most cases the mother is the carrier.

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Can down syndrome be cured?

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Patients with Down syndrome should not attempt surgical correction of symptomatic obstructive congenital heart defects. Instead they should be offered palliative care that includes the evaluation and management of other associated syndromes.

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What is down syndrome?

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People with Down syndrome often experience loneliness, social rejection and loneliness as adults. Adult-acquired deafness and intellectual disability are more common with Down syndrome than with conventional syndromes. Down syndrome is often accompanied by the formation of an abnormal placenta and, in half of the women, a spontaneous abortion. Down syndrome is characterized medically by an increased risk for sudden unexplained death in infancy and a reduced lifespan.

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What causes down syndrome?

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Down Syndrome can occur in families with normal chromosomes, and hence there is no specific genetic cause of it. The exact mechanism by which Down Syndrome affects certain cell types in the fetus remains unknown.\n

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What are common treatments for down syndrome?

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Down syndrome is often treated with antidepressants. Lactated Ringer's solution, glucose, and hydrocortisone are commonly used as a replacement-type fluid. Common medications for children with Down syndrome include: antiepileptics, thyroid hormone, anticonvulsants, and growth hormone. There are no medications routinely used for treatment of Down syndrome, nor are there any medications that can directly help children with Down Syndrome. More research is needed to provide a more detailed list of medications and their possible roles in patients with Down Syndrome.

Unverified Answer

Has inspire upper airway stimulation (uas) system proven to be more effective than a placebo?

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We found no evidence regarding the superiority of UAS in managing upper airway symptoms in pediatric patients with laryngeal spasm. Future clinical trials should focus on studying if UAS can prevent and treat upper airway symptoms in pediatric patients with laryngeal spasm.

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How does inspire upper airway stimulation (uas) system work?

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UAS is not just a breath apparatus. The user breathes as fast as possible through the device while in regular mode (without any voluntary effort) and it may be able to reduce obstructive sleep apnea, as reported by most users. However, we did not observe a clear reduction of obstructive sleep apnea in this preliminary study

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How serious can down syndrome be?

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The majority of DS cases is not serious. The complications can vary according to age and the underlying disease. The risk of DS is greatest in newborns and decreases with age. DS should not be considered a cause of death in babies, and DS is more important in the quality of life and mental outlook of elderly people.\n

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Does inspire upper airway stimulation (uas) system improve quality of life for those with down syndrome?

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The UAS System is an effective treatment for nasal mucosal hyperreactivity in patients with Down syndrome. This is the first study to report the efficacy of nasal endoscopic hyperstimulation for nasal asthma for those with Down syndrome.

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What are the common side effects of inspire upper airway stimulation (uas) system?

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This audit demonstrates the potential of a common and readily available therapy to be an effective tool for addressing a number of important chronic neurological problems. UAS appears to be effective as a first-line treatment option, and, as our audit illustrates, the benefits of treatment may be maintained for up to a year after treatment is stopped. Results from a recent clinical trial have important relevance for the planning of services for the management of neurological conditions and for the provision of clinical rehabilitation, to minimise the adverse effects of existing therapies, and to allow for early discharge from hospital.

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What is the average age someone gets down syndrome?

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If we can achieve the goals of the United Nations Millennium Development Goals, newborns with Down Syndrome in the developing world would need to be given treatment as soon as possible to delay or prevent the development of certain health problems and will need to be monitored to detect if they start developing the same type of health problems in later years. The next generation of children born with Down Syndrome should get screened and treated in a timely manner. At this stage, the children with Down Syndrome need to be taken care of in nurseries and by trained professionals, if the current health problems are left untreated it could lead to health problems such as asthma, high blood pressure, and heart disease.

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