Pediatric Post-Approval Registry
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Inspire Upper Airway Stimulation System
- Registration Number
- NCT04457154
- Lead Sponsor
- Inspire Medical Systems, Inc.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
- Subject is willing and able to provide informed consent.
- Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
- Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable, or does not have the necessary assistance, to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy < 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Registry Population Inspire Upper Airway Stimulation System Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)
- Primary Outcome Measures
Name Time Method Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time through 5 years post-implant 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.
Evaluation of device and/or procedure related adverse events over time Implant through 5 years post-implant relevant adverse events will be collected and reported
- Secondary Outcome Measures
Name Time Method Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time through 5 years post-implant 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.
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time through 5 years post-implant 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.
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time through 5 years post-implant 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.
Trial Locations
- Locations (8)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Childrens Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cincinnati Childrens Hospital
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Sewickley, Pennsylvania, United States
University of Texas Southwestern/Children's Hospital of Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital of the King's Daughters/East Virginia Medical School
🇺🇸Norfolk, Virginia, United States