Obstructive Sleep Apnea Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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