Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Study Overview
=================
Brief Summary
-----------------
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis. In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Detailed Description
-----------------
This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.

Official Title
-----------------
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Inspire therapy
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry: Capable of giving informed consent, as required per institution 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 Has a life expectancy of less than 1 year Any reason the clinician deems patient is unfit for participation in the study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADHERE<br>This group will include 250 patients who have been implanted with the Inspire therapy system, enrolled in the ADHERE Registry, and are willing to complete a follow-up home sleep apnea test (HSAT). | Device: Inspire therapy<br> <br> * Other names: ADHERE;|
| CONTROL<br>This group will include 100 patients who have been denied insurance coverage of the Inspire therapy system implant by their provider, have had no intervention (Inspire), and are willing to complete a HSAT and provide information about their OSA treatment after denial. | Other: No intervention<br> <br> * Other names: CONTROL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea Hypopnea (AHI) from Baseline to 12-Months | Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI will be determined by the AHI score at the post-titration visit compared with the pre-implant baseline score. | Baseline through 12 months | 
| Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months | The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. ESS 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. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline. | Baseline through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience with Therapy (PET) | The PET is a survey deigned to collect information about patients' experience with the Inspire therapy. Information will be collected once the therapy is activated about relative satisfaction with the therapy over time. | Through 12 months | 
| Therapy Adherence | Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic. This value can be used to quantify device use and adherence over time. | Through 12 months | 
| Advance or Additional Titrations | The patient will report the number of in-office or sleep lab device titrations completed. | Through 12 months | 
| Physical Assessment | Blood pressure, and height (in either cm or in) & weight (in either kg or lbs) will be used to calculate Body Mass Index at baseline and through study completion. | Baseline through 12 months | 
| Clinical Global Impression (CGI-I) | The Clinical Global Impression (CGI-I) is a clinician assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. During the assessment the physician rates the patient's obstructive sleep apnea by selecting 1 of 7 categories that range from very much worse to very much improved (in comparison to baseline). | Baseline through 12 months | 
| Device Data Collection | Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers. | Through 12 months | 
| Insomnia Severity Index (ISI) | The Insomnia Severity Index (ISI) is a 7 item self-report instrument that measures patient perception of both nocturnal and diurnal symptoms of insomnia. Scores range from 0 to 28, with a lower score indicating less severe insomnia. | Baseline through 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation