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

  • 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
  • Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
  • Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
  • Willing and capable of providing informed consent

Exclusion Criteria

  • Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
  • Have any condition or procedure that has compromised neurological control of the upper airway
  • Unable or do not have the necessary assistance to operate the patient programmer
  • Pregnant or plan to become pregnant
  • Require magnetic resonance imaging (MRI)
  • Have an implantable device that may be susceptible to unintended interaction with the Inspire system. Additional exclusions for study purposes only:
  • Body Mass Index (BMI) of > 35
  • Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
  • Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  • Has a terminal illness with life expectancy < 12 months
  • Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  • 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..