Pediatric Post-Approval Registry
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-21
SponsorInspire Medical Systems, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Inspire Upper Airway Stimulation System
DeviceImplant of the Inspire Upper Airway Stimulation System
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Registry Population1 intervention
Trial outcomes
Primary outcomes
1
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-implant2
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-implantSecondary outcomes
1
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-implant2
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-implant3
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.
Time frame
through 5 years post-implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov