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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: Completed NA study of Down Syndrome and Sleep Apnea, Obstructive, sponsored by Christopher Hartnick, M.D..

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

In this study, adverse events were defined as "serious" if they resulted in: (1) death; (2) a life-threatening experience; (3) in-patient hospitalization or prolongation of hospital stay; (4) a persistent or significant disability/incapacity; (5) congenital anomaly/birth defect; or (6) events that jeopardized the health of the subject or required surgical intervention.

Conditions Studied

Down Syndrome Sleep Apnea, Obstructive

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

FieldValue
Enrollment Target 42 participants
Start Date 2015-02
Est. Completion 2021-09-02
Phase NA
Christopher Hartnick, M.D.

1 total trials

What the finished NCT02344108 record still lists

NCT02344108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower).

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 lists 5 locations in 5 states (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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02344108's enrollment target sits among peer trials

42 37th of 54 higher than 18 of 54 other Down Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02344108, the US trial registry maintained by the National Library of Medicine. NCT02344108 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.