ACTIVE_NOT_RECRUITING

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Conditions

Down Syndrome Obstructive Sleep Apnea Hypoglossal nerve stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Quick Facts

Study Start:2021-06-24

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04801771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of Down syndrome * Age 10-21 years * 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	* Body mass index (BMI) above the 95th percentile for subject's age * Circumferential airway collapse at the level of the velopharynx observed during DISE * Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration) * Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest * Patients with another implantable device which could interact unintentionally with the Inspire system * Any contraindication for general anesthesia * History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries * Subject is currently taking muscle relaxant medication * Life expectancy less than 12 months * Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment * Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling * Subjects with a co-occurring diagnosis of autism spectrum disorder * Subjects that have a positive β-HCG * Subjects deemed unfit for participation by the investigator for any other reason

Inclusion Criteria

Exclusion Criteria

* Diagnosis of Down syndrome
* Age 10-21 years
* 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

* Body mass index (BMI) above the 95th percentile for subject's age
* Circumferential airway collapse at the level of the velopharynx observed during DISE
* Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration)
* Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest
* Patients with another implantable device which could interact unintentionally with the Inspire system
* Any contraindication for general anesthesia
* History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries
* Subject is currently taking muscle relaxant medication
* Life expectancy less than 12 months
* Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment
* Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling
* Subjects with a co-occurring diagnosis of autism spectrum disorder
* Subjects that have a positive β-HCG
* Subjects deemed unfit for participation by the investigator for any other reason

Contacts and Locations

Principal Investigator

Christopher Hartnick, MD

PRINCIPAL_INVESTIGATOR

The Massachusetts Eye and Ear Infirmary

Study Locations (Sites)

Children's Healthcare of Atlanta/ Emory University School of Medicine

Atlanta, Georgia, 30329

United States

Massachusetts General Hospital (Mass Eye & Ear Infirmary)

Boston, Massachusetts, 02114

United States

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

University of Texas Southwestern/Children's Hospital of Dallas

Dallas, Texas, 75207

United States

Children's Hospital of the King's Daughters/East Virginia Medical School

Norfolk, Virginia, 32507

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: Inspire Medical Systems, Inc.

Christopher Hartnick, MD, PRINCIPAL_INVESTIGATOR, The Massachusetts Eye and Ear Infirmary

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-24

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2021-06-24

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

Hypoglossal nerve stimulation

Additional Relevant MeSH Terms

Down Syndrome
Obstructive Sleep Apnea