A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea

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

• Sleep Apnea, Obstructive
• Down Syndrome

Interventions

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.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Inspire Medical Systems, Inc.

  collaborator INDUSTRY

• University of Pittsburgh

  collaborator OTHER

• Children's Hospital of The King's Daughters

  collaborator OTHER

• Christopher Hartnick, M.D.

  lead OTHER

Principal Investigators

• Christopher J Hartnick, MD · Massachusetts Eye and Ear

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2021-07-23

Completion

2021-09-02

FDA Device

Yes

Countries

• United States

Study Locations