NCT04335097 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bodapati RK, Kizer JR, Kop WJ, Kamel H, Stein PK
Addition of 24-Hour Heart Rate Variability Parameters to the Cardiovascular Health Study Stroke Risk Score and Prediction of Incident Stroke: The Cardiovascular Health Study. J Am Heart Assoc. 2017 Jul 21;6(7). pii: e004305. doi: 10.1161/JAHA.116.004305.
Meld
St. 16 (2010-2011) Report to the Storting (white paper) Summary - National Health and Care Services Plan. https://www.regjeringen.no/en/dokumenter/meld.-st.-16-2010-2011/id639794/
Melillo P, Izzo R, Orrico A, Scala P, Attanasio M, Mirra M, De Luca N, Pecchia L
Automatic prediction of cardiovascular and cerebrovascular events using heart rate variability analysis. PLoS One. 2015 Mar 20;10(3):e0118504. doi: 10.1371/journal.pone.0118
Samsudin MI, Liu N, Prabhakar SM, Chong SL, Kit Lye W, Koh ZX, Guo D, Rajesh R, Ho AFW, Ong MEH
A novel heart rate variability based risk prediction model for septic patients presenting to the emergency department. Medicine (Baltimore). 2018 Jun;97(23):e
Seamless Healthcare Monitoring Advancements in Wearable, Attachable, and Invisible Devices
Chapter 5 Ballistocardiography.
The Royal College of Physicians
National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness severity in the NHS. London: RCP; 2017. p. 1-77.
Williams B, Alberti G, Ball C, et al; Royal College for Physicians: National Early Warning Score (NEWS): Standardising the Assessment of Acute-Illness Severity in the NHS
2012London, ENG, Royal College of Physicians.

Sensor Based Vital Signs Monitoring of Patients With Clinical Manifestation of Covid 19 Disease During Home Isolation, a Randomized Feasibility Study

Clinical trial NCT04335097 - References