Hypoglossal Nerve Stimulation for Down Syndrome
Recruiting in Palo Alto (17 mi)
+7 other locations
Overseen byChristopher Hartnick, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Inspire Medical Systems, Inc.
Must not be taking: Muscle relaxants, NSAIDs
Disqualifiers: High BMI, Autism, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently taking muscle relaxant medication. Additionally, you should not use NSAIDs (non-steroidal anti-inflammatory drugs) for a week before and two weeks after the implantation surgery.
What data supports the effectiveness of the treatment Inspire Upper Airway Stimulation (UAS) System for Down Syndrome?
Research shows that the Inspire Upper Airway Stimulation (UAS) System, which stimulates the hypoglossal nerve, is effective in treating obstructive sleep apnea (OSA) by improving airflow and sleep quality. This treatment has been successful in patients who cannot use traditional therapies, suggesting it may also help those with Down Syndrome who experience similar sleep issues.12345
Is hypoglossal nerve stimulation safe for humans?
How is the Inspire Upper Airway Stimulation System treatment different from other treatments for Down syndrome-related sleep apnea?
The Inspire Upper Airway Stimulation System is unique because it is an implantable device that stimulates the hypoglossal nerve to move the tongue forward, helping to keep the airway open during sleep. This is different from other treatments like continuous positive airway pressure (CPAP), which many patients find uncomfortable, or tracheotomy, which is more invasive.35789
Eligibility Criteria
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.Inclusion Criteria
I am between 10 and 21 years old.
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
Two doctors approved my sleep study results within the last year.
See 6 more
Exclusion Criteria
I cannot have general anesthesia due to health reasons.
I am currently taking medication to relax my muscles.
I do not have any health conditions causing instability like heart failure or severe lung disease.
See 11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Implantation
Participants undergo implantation of the Inspire Upper Airway Stimulation (UAS) System
1 week
1 visit (in-person)
Treatment
Participants receive therapy with the Inspire UAS System and undergo follow-up visits
12 months
5 visits (in-person), including 4 in-lab sleep studies
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Follow-up assessments at 6 and 12 months post-implant
Treatment Details
Interventions
- Inspire Upper Airway Stimulation (UAS) System (Neurostimulation Device)
Trial OverviewThe 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.
Participant Groups
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.
Inspire Upper Airway Stimulation (UAS) System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Inspire Upper Airway Stimulation System for:
- Moderate to severe obstructive sleep apnea in adults who are intolerant to CPAP therapy
🇪🇺 Approved in European Union as Inspire Upper Airway Stimulation System for:
- Moderate to severe obstructive sleep apnea in adults who are intolerant to CPAP therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin School of Medicine and Public HealthMadison, WI
Children's Hospital of the King's Daughters/East Virginia Medical SchoolNorfolk, VA
Massachusetts General Hospital (Mass Eye & Ear Infirmary)Boston, MA
Children's Hospital of PittsburghPittsburgh, PA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Inspire Medical Systems, Inc.Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
National Institutes of Health (NIH)Collaborator
References
Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. [2022]Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation.
Upper Airway Stimulation Therapy. [2017]Traditional upper airway surgery directly modifies skeletal and soft tissue structures surrounding the airway to treat obstructive sleep apnea (OSA). Upper airway stimulation (UAS) attempts to treat upper airway obstruction and OSA by stimulating the hypoglossal nerve. The Inspire II implant has been approved for clinical UAS. Basic science data support that UAS prevents obstruction and improves airflow. Clinical results demonstrate that UAS improves respiratory sleep metrics and improves both objective and subjective self-reported sleep and quality-of-life outcomes. In a substantial number of individuals who meet inclusion criteria, UAS appears to be a viable, long-term, low-morbidity treatment of moderate-to-severe OSA.
Modified surgical approach to hypoglossal nerve stimulator implantation in the pediatric population. [2018]Upper airway stimulation with the hypoglossal nerve stimulator is a promising treatment modality for severe obstructive sleep apnea in carefully selected patients with Down syndrome. The pediatric population presents a greater variety in body habitus, including thorax size. A modified surgical approach, utilizing a medially placed, single chest incision, instead of two separate chest incisions, provides an alternative that is particularly useful for pediatric patients with small stature. As this technology is evaluated for Food and Drug Administration clearance in the pediatric population, it is important to consider modifications in surgical technique, partnering prior surgical experience with the technical support of company representatives. Laryngoscope, 128:1490-1492, 2018.
Breathing Synchronised Hypoglossal Nerve Stimulation with Inspire for Untreated Severe Obstructive Sleep Apnoea/Hypopnoea Syndrome: A Simulated Cost-Utility Analysis from a National Health Service Perspective. [2021]Hypoglossal nerve stimulation (HNS) with Inspire is a novel treatment indicated for moderate or severe obstructive sleep apnoea/hypopnoea syndrome (OSAHS), intolerant to or unable to be treated with continuous positive airway pressure (CPAP).
[Hypoglossal nerve stimulation for obstructive sleep apnoea; technique, indication and future prospects]. [2020]Hypoglossal nerve stimulation for obstructive sleep apnoea; technique, indication and future prospects Continuous positive airway pressure (CPAP) is the treatment of first choice in patients with moderate to severe obstructive sleep apnoea (OSA); however, 1 in 3 patients does not tolerate CPAP. Upper airway stimulation (UAS) is an alternative for CPAP. This is a new treatment, intended for patients with CPAP intolerance or failure. The muscles responsible for protrusion of the tongue are activated by unilateral stimulation of the hypoglossal nerve, resulting in opening up of the pharynx. Since April 2017, UAS treatment has been reimbursed for a select group of patients by the National Healthcare Institute in the Netherlands, leading to an increase in demand for UAS.
Upper Airway Stimulation in Patients with Obstructive Sleep Apnea: Long-Term Surgical Success, Respiratory Outcomes, and Patient Experience. [2023]Introduction  Upper airway stimulation (UAS) with electric activation of the hypoglossal nerve has emerged as a promising treatment for patients with moderate-to-severe obstructive sleep apnea. Objective  To retrospectively analyze objective and subjective outcome measures after long-term follow-up in obstructive sleep apnea patients receiving upper airway stimulation. Methods  An observational retrospective single-center cohort study including a consecutive series of patients diagnosed with obstructive sleep apnea receiving upper airway stimulation. Results  Twenty-five patients were included. The total median apnea-hypopnea index (AHI) significantly decreased from 37.4 to 8.7 events per hour at the 12-month follow-up ( p  < 0.001). The surgical success rate was 96%. Adverse events were reported by 28% of the patients. Conclusion  Upper airway stimulation is an effective and safe treatment for obstructive sleep apnea in patients with continuous positive airway pressure (CPAP) failure or intolerance. However, it is possible that the existing in and exclusion criteria for UAS therapy in the Netherlands have positively influenced our results.
Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea: A systematic review and meta-analysis. [2022]To evaluate the efficacy and adverse effects of hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea.
Hypoglossal Nerve Stimulator Implantation in an Adolescent With Down Syndrome and Sleep Apnea. [2022]Obstructive sleep apnea (OSA) is more common in children with Down syndrome, affecting up to 60% of patients, and may persist in up to 50% of patients after adenotonsillectomy. These children with persistent moderate to severe OSA require continuous positive airway pressure, which is often poorly tolerated, or even tracheotomy for severe cases. The hypoglossal nerve stimulator is an implantable device that produces an electrical impulse to the anterior branches of the hypoglossal nerve, resulting in tongue protrusion in response to respiratory variation. It is an effective treatment of sleep apnea in select adult patients because it allows for alleviation of tongue base collapse, improving airway obstruction. Herein we describe the first pediatric hypoglossal nerve stimulator implantation, which was performed in an adolescent with Down syndrome and refractory severe OSA (apnea hypopnea index [AHI]: 48.5 events/hour). The patient would not tolerate continuous positive airway pressure and required a long-standing tracheotomy. Hypoglossal nerve stimulator therapy was well tolerated and effective, resulting in significant improvement in the patient's OSA (overall AHI: 3.4 events/hour; AHI: 2.5-9.7 events/hour at optimal voltage settings depending on sleep stage and body position). Five months after implantation, the patient's tracheotomy was successfully removed and he continues to do well with nightly therapy.
Hypoglossal Nerve Stimulation in Adolescents With Down Syndrome and Obstructive Sleep Apnea. [2022]Obstructive sleep apnea (OSA) affects up to 60% of children with Down syndrome (DS) and may persist in half of patients after adenotonsillectomy. Children with DS who have persistent OSA often do not tolerate treatment with positive pressure airway support devices or tracheotomy for their residual moderate to severe OSA. The hypoglossal nerve stimulator is an implantable device that delivers an electrical impulse to anterior branches of the hypoglossal nerve in response to respiratory variation, resulting in tongue base protrusion that alleviates upper airway obstruction in adults.