A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02344108|
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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|