Obstructive Sleep Apnea
Conditions
Keywords
OSA
Brief summary
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
Detailed description
This study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the Inspire UAS System (implanted in a commercial setting under current labeling). Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire UAS system) who undergo different post-implant care algorithms throughout follow-up, in order to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG titration in a sub-set of patients. Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire UAS system), according to commercial labeling, will be recruited to participate in the study. A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60 subjects will be randomized (1:1) to one of two study arms.
Interventions
DIAGNOSTIC_TESTHome Sleep Testing
Two-night Home Sleep Tests (HSTs) will be conducted using commercially available Home Sleep Test equipment. The HST will be ordered by the clinical center through a HIPAA compliant HST service that has been selected by the study sponsor. The HSTs will be scored and interpreted according to AASM Guidelines by board certified sleep physicians affiliated with the HST service. The HST will be scored using the 4% oxygen desaturation rule.
Sponsors
Inspire Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient is ≥ 22 years of age; 2. Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study; 3. Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System; 4. Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient); 5. 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; 6. Patient is willing and able to return for all follow-up study visits; 7. Patient is willing to be randomized and adhere to randomization allocation; 8. Patient is willing to and capable of providing informed consent.
Exclusion criteria
1. Patient has central + mixed apneas more than \> 25% of the total AHI; 2. 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; 3. Patient is pregnant or plans to become pregnant; 4. Patient has a terminal illness with life expectancy \< 12 months; 5. Any other reason the investigator deems that the patient is unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms | 6 months post-activation | The AHI endpoint will be determined by performing three equivalency tests for the following: Absolute AHI and, change in AHI. All comparisons will be done on the treatment AHI at 6 months between the control group and the home monitoring group. The objective is to demonstrate the equivalence in AHI, change in AHI, and response rate between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms | 6 months post-activation | The Epworth Sleepiness Scale (ESS) endpoint will be determined by performing an equivalence test for the ESS score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ESS score to be equivalent between the two groups. H0: \|x ̃\_diff \|\>2 Ha: \|x ̃\_diff \|≤2 where x ̃\_diff is the median of differences (location shift) in the ESS score between the two groups. As the ESS score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -2 and 2 will be used as this is the defined meaningful clinical difference based on the AASM guidelines8. |
| Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms | 6 months post-activation | The Oxygen Desaturation Index (ODI) endpoint will be determined by performing an equivalence test for the ODI score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ODI score to be equivalent between the two groups. H0: \|x ̃\_diff \|\>15 Ha: \|x ̃\_diff \|≤15 where x ̃\_diff is the median of differences (location shift) in the ODI score between the two groups. As the ODI score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. ODI is closely related to AHI and therefore an equivalence margin of -15 and 15 will be used. |
| Comparison of Therapy Usage (hours per week), between the two randomization arms | 6 months post-activation | The therapy usage endpoint will be determined by performing an equivalence test for the average therapy usage at 6 months between the control group and the home monitoring group. The objective is to demonstrate therapy usage to be equivalent between the two groups. H0: \|x ̃\_diff \|\>0.5 hrs Ha: \|x ̃\_diff \|≤0.5 hrs where x ̃\_diff is the median of differences (location shift) in therapy usage between the two groups. As the treatment therapy usage at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -0.5 and 0.5 hrs will be used as this is the defined meaningful clinical difference based on the AASM guidelines8. |
Countries
United States
Outcome results
None listed