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Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

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Does sleep apnea affect heart rate variability during wakefulness?
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1 min read time
Obstructive sleep apnea (OSA) is a common sleep disorder associated with increased cardiovascular disease risk. However, the relationship between OSA severity and multiple heart rate variability (HRV) metrics during wakefulness remains an open question.
In another excellent paper co-authored by one of our BSC team members in collaboration with the Sleep Apnea Global Interdisciplinary Consortium (SAGIC), this question is further clarified! In this study, the authors show that HRV measures collected during a 5-minute period of wakefulness prior to an overnight sleep study were significantly associated with higher OSA severity. The observed differences are consistent with worse cardiovascular abnormalities in the most severe OSA group.
Fantastic job, Brendan Keenan and co-authors!
Interested in understanding more about the correlation between OSA and HRV? Check this article in Sleep: doi.org/10.1093/sleep/zsab018

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Receive updates on clinical trial methodology, regulatory developments, FDA guidance, and practical biostatistical insights drawn from real-world experience.

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Receive updates on clinical trial methodology, regulatory developments, FDA guidance, and practical biostatistical insights drawn from real-world experience.
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Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
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Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
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