Dual-Site Stimulation for OSA (BOOST Study)
N
Noah Parker, MD
Primary Investigator
Enrolling By Invitation
22-100 years
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
What is this study about?
The objective of this early feasibility study is to assess the safety of chronic dual site stimulation by adding infrahyoid stimulation in non-responding patients with pre-existing single-site hypoglossal nerve stimulation.
This study will also assess whether the secondary Inspire System can achieve the intended purpose of causing inferior displacement of the thyroid cartilage during stimulation and thereby establishing a proof of principle for dual site stimulation.
THIS STUDY IS ENROLLING BY INVITATION ONLY - The clinical centers participating in this study will be identifying and contacting potentially eligible patients who have previously been implanted with the Inspire Upper
Airway Stimulation system stimulating the hypoglossal nerve to receive adary infrahyoid stimulation system to additionally stimulate
innervating nerves ofthe infrahyoid muscles, such as the ansa cervicalisve (have had a therapy titration session, a follow-up sleep study, and have undergone therapy optimization).
Detailed description of study
What will happen during study participation?
- Screening and baseline - The screening and baseline activities may occur over several clinic visits and may include information and/or tests that were performed locally within the appropriate time frame prior to obtaining consent (this will include obtaining medical history and demographic information, a routine head and neck physical examination, including a functional tongue and neck
exam will be performed, and a drug induced sleep endoscopy (DISE) will be performed to assess the upper airway of patients for obvious obstructions that are unlikely to resolve through stimulation. - Pre-implant testing - If eligible, all patients enrolled will participate in pre-implant testing, including overnight PSG (if applicable), prior to undergoing a surgical procedure to implant the secondary Inspire System
- Surgical implantation of device - During the surgical procedure, an additional stimulation lead, sensing lead and IPG will be implanted in the participant. The existing patient implant card will be replaced with the new implant card containing both systems information and be given to the patient.
- Follow-up visits - Patients will undergo assessments during additional study visits over a period of up to 12 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: obstrucitve sleep apnea, OSA
-
Age: Between 22 Years - 100 Years
-
Gender: All
Inclusion criteria:
- Patient has been implanted with Inspire Upper Airway Stimulation System that has been confirmed to be functioning adequately through a device check
- Documented history of residual AHI >30 with HNS, documented through recent (past 6 months) PSG
- Subject is willing and able to have stimulation hardware permanently implanted, and to use the patient remotes to activate the dual stimulation therapy; and
- Subject is willing and able to return for follow-up visits and undergo in-lab sleep studies.
Updated on
01 Aug 2024.
Study ID: OTHN-INSPIRE-BOOST, 19882
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