A Pilot Study to Evaluate the Safety and Efficacy of 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02344108|
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Down Syndrome||Device: Inspire® Upper Airway Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved under P130008 for the treatment of obstructive sleep apnea||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 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|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Intervention Group
Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, will undergo surgical placement of a hypoglossal nerve stimulator. The stimulator 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 3024 IPG, and any subsequent iteration thereof that are approved under P130008 for the treatment of obstructive sleep apnea
Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.
Other Name: hypoglossal nerve stimulator
- Number of patients with adverse events [ Time Frame: 1 year ]Study subjects will be monitored closely to verify that implantation may be performed safely in this population.
- Frequency of device usage [ Time Frame: 1 year ]Study subjects will be monitored closely to determine frequency of usage through self-report logs and device interrogation.
- 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
|Contact: Christopher J. Hartnick, MDfirstname.lastname@example.org|
|Contact: Gillian R. Diercks, MDemail@example.com|
|United States, Georgia|
|Henrietta Egleston Hospital for Children||Recruiting|
|Atlanta, Georgia, United States, 30329|
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|United States, Massachusetts|
|Massachusetts Eye and Ear||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Christopher Hartnick, MD 617-523-7900 firstname.lastname@example.org|
|Sub-Investigator: Gillian Diercks, MD|
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|Cincinnati Children's Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45229|
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|Children's Hospital of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
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