A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT02344108 |
Recruitment Status :
Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : September 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Sleep Apnea, Obstructive Down Syndrome | Device: Inspire® Upper Airway Simulation System (Model 3028 IPG ) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea |
Actual Study Start Date : | February 2015 |
Estimated Primary Completion Date : | August 31, 2021 |
Estimated Study Completion Date : | August 31, 2021 |

Arm | Intervention/treatment |
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Experimental: Inspire® Upper Airway Simulation System
Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, will undergo surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator will be activated one month after surgery and subjects will undergo repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects will be followed for one year to determine safety and efficacy of the device.
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Device: Inspire® Upper Airway Simulation System (Model 3028 IPG )
Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.
Other Name: hypoglossal nerve stimulator |
- Assess the safety and efficacy of hypoglossal nerve stimulator placement for the treatment of obstructive sleep apnea in adolescents with Down Syndrome. [ Time Frame: 1 year ]Safety of implantation will be monitored throughout the perioperative period and unanticipated and anticipated adverse device related events will be recorded. Effectiveness in the treatment of obstructive sleep apnea will be measured using standard in-lab PSG measures, including oxygen level, partial and complete airway obstruction, and arousals. Improvement will be defined as a 50% or more decrease in baseline AHI.
- Efficacy of implantation in adolescents and young adults with Down syndrome (Sleep questionnaires) [ Time Frame: 1 year ]Sleep questionnaires will be given to assess subjective changes in response to treatment. Scheduled polysomnograms will be performed to evaluate objective changes in sleep patterns in response to the device.

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Ages Eligible for Study: | 10 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Only children and young adults with Down Syndrome age 10-21 years with prior adenotonsillectomy will be considered for the study.
- Subjects must have BMI <95th percentile for age
- All subjects must have moderate to severe OSA (AHI >10, AHI <50, no more than 25% AHI attributable to central events) based on prior in-lab polysomnography performed after adenotonsillectomy.
- Subjects must have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device.
- Children and their parents must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative polysomnography, and questionnaire completion.
- Children's parents 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 must be proficient in English for this pilot study in order to ensure full disclosure during the consent process, as well as have the ability to communicate with all staff, at all times, regarding any questions about participation or concerns about this device.
- In order to participate, subjects will require written consent from both parents. All study subjects must provide written assent as well.
Exclusion Criteria:
- Subjects will be excluded if they meet the following criteria: BMI >95th percentile for age, apnea hypopnea index (AHI) <10 or >50 on in-lab polysomnography (PSG), central or mixed apneas accounting for >25% of the total AHI, any anatomic finding on physical exam or drug induced sleep endoscopy (DISE) that would compromise the performance of stimulation (e.g. concentric soft palate collapse), other medical conditions resulting in medical instability (e.g. 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), history of cholesteatoma, or patients with another implantable device which could interact unintentionally with the Inspire system.
- Subjects in whom general anesthesia for a surgical procedure is contraindicated due to other medical illnesses or conditions will be excluded.
- Subjects with a life expectancy < 12 months will be excluded.
- Subjects who are unable to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment, will be excluded.
- Subjects with a history of bleeding or clotting disorders and those on blood thinning or NSAID medications will be excluded from participation.
- Subjects taking muscle relaxant medication will be excluded from participation.
- Female subjects who are pregnant or plan to become pregnant during the study period will be excluded. All female subjects will undergo urine beta-HCG testing on the day of procedures requiring general anesthesia (DISE, implantation, and any other unanticipated surgical procedures related to implantation). Subjects who are positive will not undergo surgical implantation or procedures under general anesthesia.
- Subjects deemed unfit for participation by investigators or any other reason will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344108
United States, Georgia | |
Children's Healthcare of Atlanta - Egleston Hospital | |
Atlanta, Georgia, United States, 30329 | |
United States, Massachusetts | |
Massachusetts Eye and Ear | |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
Cincinnati Children's Hospital | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, Virginia | |
Children's Hospital of The King's Daughters | |
Norfolk, Virginia, United States, 23507 |
Principal Investigator: | Christopher J Hartnick, MD | Massachusetts Eye and Ear |
Responsible Party: | Christopher Hartnick, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary |
ClinicalTrials.gov Identifier: | NCT02344108 |
Other Study ID Numbers: |
14-146H 2019P001786 ( Other Identifier: Partners Human Research Committee ) |
First Posted: | January 22, 2015 Key Record Dates |
Last Update Posted: | September 17, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Down Syndrome Syndrome Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Dyssomnias Sleep Wake Disorders Nervous System Diseases Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |