Clinical trial NCT04457154: Pediatric Post-Approval Registry
Official title: Inspire Pediatric Post-Approval Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Pediatric
Apnea-hypopnea Index
Sleep Breathing Disorders
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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

Eligibility criteria: Inclusion Criteria:

1. Subject is between 18 and 21 years of age;
2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
7. 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;
8. Subject is willing and able to provide informed consent.

Exclusion Criteria:

1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
2. 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;
3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
5. Subject is pregnant or plans to become pregnant;
6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
7. Subject has a terminal illness with life expectancy \< 12 months;
8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Primary outcomes:
measure: Evaluation of device and/or procedure related adverse events over time
timeFrame: Implant through 5 years post-implant
measure: Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
timeFrame: through 5 years post-implant
Secondary outcomes:
measure: Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
timeFrame: through 5 years post-implant
measure: Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
timeFrame: through 5 years post-implant
measure: Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
timeFrame: through 5 years post-implant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Sewickley
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern/Children's Hospital of Dallas
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters/East Virginia Medical School
state: Virginia
Study officials:
References: