Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Sleep Apnea, OSA, Inspire, Obstructive Sleep Apnea
Brief summary
The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.
Interventions
DEVICEInspire UAS System
Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.
Sponsors
Inspire Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry: 1. Capable of giving informed consent, as required per institution 2. Willing to return for routine clinic visits as required for Inspire therapy management
Exclusion criteria
Any patient who meets any of the following criteria will not be eligible to participate in the registry: 1. Has a life expectancy of less than one year 2. Any reason the clinician deems patient is unfit for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | Total AHI, supine and non-supine AHI, documented as events/hour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care. | The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity. |
| Epworth Sleepiness Scale (ESS) | ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care. | The ESS is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations13. The ESS has been validated primarily in OSA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience with Therapy (PET) | PET will be collected at follow-up visits after device activation, if available. | The PET is a survey designed to collect information about patient's experience with the Inspire therapy. |
| Maintenance of Wakefulness Test (MWT) | Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available. | The maintenance of wakefulness test is used to measure a person's ability to stay awake during a defined period of time. |
| DISE VOTE Classification | DISE VOTE Score will be collected, if available, at baseline. | A Drug-Induced Sleep Endoscopy (DISE) is a diagnostic, standard of care procedure performed as part of the evaluation for airway surgeries (including implant of the Inspire System). The DISE is utilized to visualize the patient's airway obstruction. |
| Adverse Events | The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints. | Both serious and non-serious procedure-related and device/therapy related adverse events will be collected and reported. |
| Therapy Use | Therapy use will be collected at follow-up visits after device activation, if available. | Therapy use, reported as hours of use per week, is recorded during follow-up visits and will be collected from the Inspire physician programmer. |
| Functional Outcomes of Sleep Questionnaire (FOSQ-30) | FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care. | The FOSQ-30 is a validated, quality of life measurement that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is commonly used in the clinical evaluation and management of OSA. |
Countries
Austria, Belgium, France, Germany, Netherlands, Switzerland, United Kingdom
Contacts
Primary ContactElyse Ebeling
Outcome results
None listed