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NCT02344108 · ClinicalTrials.gov registry record · NA
A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
A NA study of Down Syndrome and Sleep Apnea, Obstructive, sponsored by Christopher Hartnick, M.D..
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 5
- Study locations
NCT02344108 is a NA study of Down Syndrome and Sleep Apnea, Obstructive that has completed, run by Christopher Hartnick, M.D.. The registered enrollment target is 42 participants, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT02344108, a NA study of Down Syndrome and Sleep Apnea, Obstructive, has completed, sponsored by Christopher Hartnick, M.D..
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 5
- Study locations
Study Summary
Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is associated with adverse behavior and quality of life, as well as long term cardiopulmonary system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder, with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a higher incidence of OSA than the general pediatric population, with rates of 30-60%, resulting in increased morbidity and decreased quality of life for affected individuals. In children, adenotonsillectomy (T\&A) is often a contributing factor to OSA, and adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T\&A for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent obstruction is attributed to anatomic and physiologic differences in this population, including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil hypertrophy. This pilot study is designed to determine if the 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, which has already been approved for use in adults with OSA, can be safely implanted and used in adolescents and young adults with Down Syndrome.
Conditions Studied
Interventions
- DEVICE Inspire® Upper Airway Simulation System (Model 3028 IPG )
Study Locations (5)
Georgia
- Children's Healthcare of Atlanta - Egleston Hospital - Atlanta
Massachusetts
- Massachusetts Eye and Ear - Boston
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Virginia
- Children's Hospital of The King's Daughters - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-02 |
| Est. Completion | 2021-09-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02344108
The ClinicalTrials.gov registry entry for NCT02344108 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower). The listed sponsor is Christopher Hartnick, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Inspire® Upper Airway Simulation System (Model 3028 IPG ) is the first listed.
NCT02344108 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Georgia, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT02344108 about?
NCT02344108 is a clinical study titled "A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea". Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is associated with adverse behavior and quality of life, as well as long term cardiopulmonary system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder, with a incidence of approxima...
What is the current status of trial NCT02344108?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2015-02. Estimated completion is 2021-09-02.
What conditions does trial NCT02344108 study?
This clinical trial studies the following conditions: Down Syndrome, Sleep Apnea, Obstructive.
What interventions are being tested in trial NCT02344108?
The interventions under investigation include: Inspire® Upper Airway Simulation System (Model 3028 IPG ) (DEVICE).
Who is sponsoring clinical trial NCT02344108?
This trial is sponsored by Christopher Hartnick, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02344108 being conducted?
This trial has 5 study locations across Georgia, Massachusetts, Ohio, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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