This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant. Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures. This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States. Study data will be collected at the following timepoints: Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant 1, 2, 3, 4, 5 years post-implant
Study Type
OBSERVATIONAL
Enrollment
60
Implant of the Inspire Upper Airway Stimulation System
Childrens Hospital of Colorado
Aurora, Colorado, United States
RECRUITINGChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
TERMINATEDDuke University
Durham, North Carolina, United States
Evaluation of device and/or procedure related adverse events over time
relevant adverse events will be collected and reported
Time frame: Implant through 5 years post-implant
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
Time frame: through 5 years post-implant
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.
Time frame: through 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) \< 90%. A lower T90 indicates less severe sleep apnea.
Time frame: through 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.
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Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChildren's Hospital of Pittsburgh
Sewickley, Pennsylvania, United States
RECRUITINGUniversity of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas, United States
RECRUITINGChildren's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia, United States
RECRUITINGTime frame: through 5 years post-implant