Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing) (HOME)
Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥ 22 years of age;
- Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
- Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
- Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
- Patient is willing to utilize study equipment at home including Home Sleep Test (HST) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol;
- Patient is willing and able to return for all follow-up study visits;
- Patient is willing to be randomized and adhere to randomization allocation;
- Patient is willing to and capable of providing informed consent.
Exclusion Criteria:
- Patient has central + mixed apneas more than > 25% of the total AHI;
- Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the Inspire UAS System;
- Patient is pregnant or plans to become pregnant;
- Patient has a terminal illness with life expectancy < 12 months;
- Any other reason the investigator deems that the patient is unfit for participation in the study.
Sites / Locations
- Indiana University School of Medicine
- Massachusetts Eye and Ear Infirmary
- Cleveland Clinic Foundation
- Ohio Sleep Medicine Institute
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Control
Home Monitoring
Subjects in this group will be implanted with the Inspire UAS system and will undergo a standard in-lab PSG titration study at approximately 3 months post-activation and a 2-night HST at approximately 6 months post-activation
Subjects who have undergone implant of the Inspire UAS System and are randomized to this group will undergo a 2-night HST at 3 months post-activation. Depending on the results of the 2-night HST, the subject will either (a) undergo a PSG titration at 5 months post-activation and a 2-night HST at 6 months post-activation OR (b) undergo only a 2-night HST at approximately 6 months post-activation