Clinical trial NCT02293746: Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study
Official title: Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
OSA
neurostimulation
hypoglossal nerve
tongue
upper airway stimulation
surgery
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Inspire Upper Airway Stimulation System
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Reported SAEs / Procedure & Device Related AEs
timeFrame: 12 months post-implant
Secondary outcomes:
measure: Change from Baseline OSA at 12 Months
timeFrame: 12 months post-implant
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Klinik für HNO-Heilkunde/HNO-Schlaflabor
city: Mannheim
country: Germany
facility: Universitäts-HNO-Klinik Mannheim
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
Study officials:
affiliation: Klinikum rechts der Isar der Technischen Universität München
name: Clemens Heiser, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäts-HNO-Klinik Mannheim
name: Joachim T. Maurer, OA Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für HNO-Heilkunde/HNO-Schlaflabor
name: Armin Steffen, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofauer B, Philip P, Wirth M, Knopf A, Heiser C. Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea. Sleep Breath. 2017 Dec;21(4):901-908. doi: 10.1007/s11325-017-1519-0. Epub 2017 May 31.
citation: Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B. Palatoglossus coupling in selective upper airway stimulation. Laryngoscope. 2017 Oct;127(10):E378-E383. doi: 10.1002/lary.26487. Epub 2017 Jan 20.