Inspire® Upper Airway Stimulation System (RCT)

Inspire® Upper Airway Stimulation System: Randomized Control Trial / European Post-Market Study

The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Inspire® Upper Airway Stimulation (UAS) System

Detailed Description

This study is a prospective, multi-center, randomized controlled study with a delayed start arm, conducted under a common implant protocol.

Up to 40 study subjects will be implanted at up to six centers in Europe. Subjects will be evaluated at baseline, implant, post-op (randomized) and 1-, 2-, 3,- 4- and 6-months post-implant.

Baseline data will include collection of demographics and medical history, completion of a physical exam, Functional Tongue Exam (FTE), and subject quality of life (QoL) questionnaires (Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS)). Adverse event data will be collected from the time of baseline testing through the 6-month study follow-up.

Implant eligibility assessments will include home sleep testing (HST), a surgical consultation and a drug induced sedated endoscopy (DISE) to determine if the subject is a qualified candidate for implant.

Subjects meeting all baseline and pre-screening requirements will be implanted with the Inspire system. Intra- and post- operative procedure data will be collected. Subjects will be seen for a post-operative check one week after implant. During this visit, subjects will be randomized 1:1 to the ACTIVE group or the DELAY group. However, the Inspire system will not be activated (turned "on") during the first month post-implant to allow for post-surgical healing.

Only subjects randomized to the ACTIVE group will return for the 1-month follow-up visit at which time the device will be activated (turned "on"). The subjects will be provided with a patient remote and instructed on its use. These ACTIVE arm subjects will be instructed to use their Inspire system on a nightly basis and return for a 2-month visit for an in-laboratory sleep study to complete device titration.

All subjects (ACTIVE and DELAY) return for the 3-month visit to complete a HST (DELAY subjects' therapy will remain off during the HST). In addition, QoL and patient satisfaction surveys, Functional Tongue Exam (FTE), and general health assessments, including adverse event review, will be collected. Subjects in the DELAY arm will have their therapy activated at the end of the 3 month visit, and return for a 4-month visit for an in-laboratory sleep study to complete device titration. All subjects will return for a 6-month and final visit where a two-night HST will be completed. In addition, QoL and patient satisfaction surveys, physical exam and FTE data will be collected; a device check will be completed as well as adverse event review. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis. Safety data will be collected throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Universitair Ziekenhuis Antwerpen
• Germany
  • Lübeck, Germany, 23538
    • Klinik für HNO-Heilkunde/HNO-Schlaflabor
  • Mannheim, Germany, D-68135
    • Universitäts-HNO-Klinik Mannheim
  • München, Germany, D-81675
    • Klinikum Rechts Der Isar Der Technischen Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet the requirements per current CE Mark labeling
2. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote 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:

1. Do not meet any contraindications per current CE Mark labeling
2. Body Mass Index (BMI) of > 35
3. Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
4. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
5. Has a terminal illness with life expectancy < 12 months
6. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
7. Any other reason the investigator deems subject is unfit for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote to activate the therapy; Other Names: Inspire® Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline OSA at 3 Months	The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study.	3 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Reported SAEs / Procedure & Device Related AEs	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.	6 months post-implant
Change from Baseline OSA at 6 Months	AHI at the 6-month follow-up will be compared to the AHI at baseline in both the ACTIVE and DELAY groups.	6 months post-implant
Change from Baseline Breathing Indices at 6 Months	Sleep disordered breathing indices at the 6-month follow-up will be compared to the breathing indices at baseline.	6 months post-implant
Change from Baseline Quality of Life Questionnaires (QoL)	Quality of Life (QoL) questionnaires at the 6-month visit will be compared to the QoL questionnaires at baseline.	6 months post-implant

Collaborators and Investigators

• Sponsor: Inspire Medical Systems, Inc.
• Investigators: Principal Investigator: Joachim T Maurer, OA Dr. med., Universitäts-HNO-Klinik Mannheim; Principal Investigator: Clemens Heiser, Dr. med., Klinikum Rechts Der Isar Der Technischen Universität München; Principal Investigator: Armin Steffen, PD Dr. med., Klinik für HNO-Heilkunde/HNO-Schlaflabor; Principal Investigator: Olivier Vanderveken, Prof. dr., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: OSA; Obstructive Sleep Apnea; surgery; neurostimulation; tongue; upper airway stimulation; hypoglossal nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2015-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes