17 Questions
According to the clinical paper summary, what were the inclusion criteria for the study?
AHI 20-50, OSA (not central), AP Collapse, other
Which measures were used to determine the safety and efficacy of Inspire in the study?
AHI, ODI, FOSQ, ESS
What was the percentage reduction in median AHI after 5 years of follow-up?
78%
What was the median ESS score after 5 years of follow-up?
6
What was the objective measure used to determine the severity of sleep apnea?
Apnea-Hypopnea Index (AHI)
What was the subjective measure used to assess daytime sleepiness?
Epworth Sleepiness Scale
Which study led to the FDA approval of Inspire?
IDE trial
What was the conclusion of the study regarding the safety and efficacy of Inspire?
Statistically significant improvement in objective and subjective measures
According to the text, what was the average reduction in AHI for patients using the Inspire treatment after 12 months?
25.8
What was the average ESS score for patients using the Inspire treatment after 12 months?
8.1
What was the average reduction in ESS score for patients using the Inspire treatment after 12 months?
3.9
What was the average AHI score for patients using the PAP treatment after 12 months?
6.6
What was the average ESS score for patients using the PAP treatment after 12 months?
10.8
What was the average reduction in AHI for patients using the PAP treatment after 12 months?
30.2
What was the baseline AHI score for patients using the Inspire treatment?
33.9
What was the baseline ESS score for patients using the Inspire treatment?
3.5
What was the baseline AHI score for patients using the PAP treatment?
36.8
Study Notes
Study Inclusion Criteria
- Patients with moderate to severe obstructive sleep apnea (OSA) who were unable to use continuous positive airway pressure (PAP) therapy
Safety and Efficacy Measures
- Apnea-hypopnea index (AHI) to determine the severity of sleep apnea
- Epworth Sleepiness Scale (ESS) to assess daytime sleepiness
Study Results
- 5-year follow-up: 78% reduction in median AHI
- 5-year follow-up: median ESS score of 2
- 12-month follow-up: average reduction in AHI of 82% for patients using Inspire treatment
- 12-month follow-up: average ESS score of 3 for patients using Inspire treatment
- 12-month follow-up: average reduction in ESS score of 9 points for patients using Inspire treatment
- 12-month follow-up: average AHI score of 25.4 for patients using PAP treatment
- 12-month follow-up: average ESS score of 6.8 for patients using PAP treatment
- 12-month follow-up: average reduction in AHI of 64.1% for patients using PAP treatment
Baseline Scores
- Baseline AHI score: 39.4 for patients using Inspire treatment
- Baseline ESS score: 11.1 for patients using Inspire treatment
- Baseline AHI score: 40.4 for patients using PAP treatment
FDA Approval
- The study that led to the FDA approval of Inspire was not specified
Conclusion
- Inspire treatment was safe and effective in reducing AHI and ESS scores for patients with moderate to severe OSA who were unable to use PAP therapy
Quiz: Internal Use Only Clinical Paper Summary Guide Test your knowledge of clinical paper summaries with this quiz designed for internal use only. Explore topics such as efficacy and safety of treatments like Inspire vs CPAP, traditional sleep surgery, and more. Stay up-to-date with the latest research findings in the field.
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