Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Inspire® Upper Airway Stimulation (UAS) System

• Registration Number: NCT02293746
• Lead Sponsor: Inspire Medical Systems, Inc.

Brief Summary

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

Detailed Description

This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control.

The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis.

Post-implant, procedure- and device-related events, QoL questionnaires, therapy usage and device adjustment data will be collected. Sleep study data will collected during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs At 6 and 12 months post-implant, 2-night home sleep testing will be completed. Safety data will be collected throughout the study. Subjects will be exited from the study following the 12-month visits.

The subject population will consist of otherwise healthy men and women that are at least 21 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with study requirements for the specified follow-up duration, 3) Met all inclusion and exclusion criteria of this protocol.

Up to 60 subjects will be implanted at up to 5 sites in Germany.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-18
• Primary Completion: 2016-12-11
• Study Completion: 2017-01-09
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Likely suffer moderate-to-severe OSA based on history and physical, or have an established diagnosis of OSA (≥ 15 AHI<65) based on a prior sleep test
2. Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
3. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
4. Willing and capable of providing informed consent

Exclusion Criteria

Contraindications

1. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate

2. Have any condition or procedure that has compromised neurological control of the upper airway

3. Unable or do not have the necessary assistance to operate the patient programmer

4. Pregnant or plan to become pregnant

5. Require magnetic resonance imaging (MRI)

6. Have an implantable device that may be susceptible to unintended interaction with the Inspire system.

   Additional exclusions for study purposes only:

7. Body Mass Index (BMI) of > 35

8. Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)

9. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator

10. Has a terminal illness with life expectancy < 12 months

11. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing

12. Any other reason the investigator deems subject is unfit for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inspire® UAS System	Inspire® Upper Airway Stimulation (UAS) System	This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.

Primary Outcome Measures

Name	Time	Method
Number of Reported SAEs / Procedure & Device Related AEs	12 months post-implant	Safety of the therapy will be assessed via the description of all reported SAEs and all procedure- or device-related AEs. Adverse events will be summarized by seriousness, severity, relatedness to the device and/or procedure and temporal relationship to the procedure. No formal statistical hypotheses will be tested. Only device- or procedure-related AEs will be collected in this post-market study.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline OSA at 12 Months	12 months post-implant	Frequencies and description statistics will be used to describe the data gathered in this study. A statistical comparison of pre-implant baseline and follow-up data may be performed.; Efficacy endpoints will evaluate changes in subjects' quality of life (QoL) and Obstructive Sleep Apnea (OSA) severity through: 1. QoL: Epworth Sleepiness Scale: improvement from baseline to 12 months; 2. QoL: Functional Outcomes of Sleepiness Questionnaire: improvement from baseline to 12 months; 3. OSA Severity: Oxygen Desaturation Index: Reduction at 12 months as compared to baseline.; 4. OSA Severity: Apnea Hypopnea Index: Reduction at 12 months as compared to baseline.

Trial Locations

Locations (3)

Universitäts-HNO-Klinik Mannheim; 🇩🇪 Mannheim, Germany

Klinik für HNO-Heilkunde/HNO-Schlaflabor; 🇩🇪 Lübeck, Germany

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany