NCT06283771 - 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)

Agarwal DK, Viers BR, Rivera ME, Nienow DA, Frank I, Tollefson MK, Gettman MT
Physical activity monitors can be successfully implemented to assess perioperative activity in urologic surgery. Mhealth. 2018 Sep 26;4:43. doi: 10.21037/mhealth.2018.09.05. eCollection 2018.
Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA
Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.
Baskan, A
, & Goncu-Berk, G. (2022). User Experience of Wearable Technologies: A Comparative Analysis of Textile-Based and Accessory-Based Wearable Products. Applied Sciences. 12(21), 11154. https://doi.org/10.3390/app122111154.
Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB
Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4.
Burns A, Adeli H
Wearable technology for patients with brain and spinal cord injuries. Rev Neurosci. 2017 Nov 27;28(8):913-920. doi: 10.1515/revneuro-2017-0035.
Castellani JW, Young AJ
Human physiological responses to cold exposure: Acute responses and acclimatization to prolonged exposure. Auton Neurosci. 2016 Apr;196:63-74. doi: 10.1016/j.autneu.2016.02.009. Epub 2016 Feb 21.

The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering in Healthy Volunteers

Clinical trial NCT06283771 - References