Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment inspire® upper airway stimulation (uas) system
Phase phase 4
Sponsor Inspire Medical Systems, Inc.
Start date June 2014
End date April 2016
Trial size 60 participants
Trial identifier NCT02293746, 2014-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.
inspire® upper airway stimulation (uas) system Inspire® Therapy
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.

Primary Outcomes

Measure
Number of Reported SAEs / Procedure & Device Related AEs
time frame: 12 months post-implant

Secondary Outcomes

Measure
Change from Baseline OSA at 12 Months
time frame: 12 months post-implant

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872
Principal investigator Clemens Heiser, Dr. med.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Inspire Medical Systems, Inc..