Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study (NCT07113288) | Clinical Trial Compass
RecruitingNot Applicable
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
United States70 participantsStarted 2025-07-31
Plain-language summary
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is at least 18 years of age;
✓. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32\<BMI≤40 kg/m2;
✓. Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI \> 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (\> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
✓. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
✓. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study;
✓. Subject is willing and able to provide informed consent.
Exclusion criteria
✕. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);
✕. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
✕. Subject has any condition or procedure that has compromised neurological control of the upper airway;
What they're measuring
1
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)