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

Obstructive Sleep Apnea Clinical Trial

Official title:

Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293746
• Other study ID #: 2014-002
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: January 9, 2017

Study information

• Verified date: June 2020
• Source: Inspire Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 9, 2017
• Est. primary completion date: December 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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 is a permanent, implantable therapy device, which consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the patient receives a remove to activate the therapy.

Locations

Country	Name	City	State
Germany	Klinik für HNO-Heilkunde/HNO-Schlaflabor	Lübeck
Germany	Universitäts-HNO-Klinik Mannheim	Mannheim
Germany	Klinikum rechts der Isar der Technischen Universität München	München

Sponsors (1)

Lead Sponsor	Collaborator
Inspire Medical Systems, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months post-implant
Secondary	Change from Baseline OSA at 12 Months	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: QoL: Epworth Sleepiness Scale: improvement from baseline to 12 months; QoL: Functional Outcomes of Sleepiness Questionnaire: improvement from baseline to 12 months; OSA Severity: Oxygen Desaturation Index: Reduction at 12 months as compared to baseline.; OSA Severity: Apnea Hypopnea Index: Reduction at 12 months as compared to baseline.	12 months post-implant

External Links

•   Peer-reviewed publication/results (Laryngoscope 2018)