Phase IV Trial Completed: Novel Plant-Based PeptiSleep vs Placebo for Sleep Quality Enhancement — Digital Health Integration Study Results Pending

References

1. 1.Adams, R. J., Appleton, S. L., Taylor, A. W., Gill, T. K., Lang, C., McEvoy, R. D., & Antic, N. A. (2017). Sleep health of Australian adults in 2016: results of the 2016 Sleep Health Foundation national survey. Sleep Medicine, 43, 13-19. https://doi.org/10.1016/j.sleep.2017.03.018
2. 2.Australian Government Department of Health. (2023). Clinical Trials in Australia: Annual Report 2022-23. Therapeutic Goods Administration. https://www.tga.gov.au/clinical-trials-annual-report
3. 3.Billioti de Gage, S., Moride, Y., Ducruet, T., Kurth, T., Verdoux, H., Tournier, M., Pariente, A., & Bégaud, B. (2012). Benzodiazepine use and risk of dementia: prospective population based study. BMJ, 345, e6231. https://doi.org/10.1136/bmj.e6231
4. 4.Buysse, D. J., Ancoli-Israel, S., Edinger, J. D., Lichstein, K. L., & Morin, C. M. (2006). Recommendations for a standard research assessment of insomnia. Sleep, 29(9), 1155-1173. https://doi.org/10.1093/sleep/29.9.1155
5. 5.Cicero, A. F., Fogacci, F., & Colletti, A. (2022). Bioactive peptides and sleep quality: A systematic review. Nutrients, 14(19), 4142. https://doi.org/10.3390/nu14194142
6. 6.Hillman, D., Mitchell, S., Streatfeild, J., Burns, C., Bruck, D., & Pezzullo, L. (2018). The economic cost of inadequate sleep. Sleep, 41(8), zsy083. https://doi.org/10.1093/sleep/zsy083
7. 7.Irish, L. A., Kline, C. E., Gunn, H. E., Buysse, D. J., & Hall, M. H. (2015). The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Medicine Reviews, 22, 23-36. https://doi.org/10.1016/j.smrv.2014.10.001
8. 8.Khosla, S., Deak, M. C., Gault, D., Goldstein, C. A., Hwang, D., Kwon, Y., O'Hearn, D., Schutte-Rodin, S., Yurcheshen, M., & Rosen, I. M. (2018). Consumer sleep technology: an American Academy of Sleep Medicine position statement. Journal of Clinical Sleep Medicine, 14(5), 877-880. https://doi.org/10.5664/jcsm.7128
9. 9.Menghini, L., Gianfagna, F., & Cappuccio, F. P. (2021). Wearable devices for assessment of sleep disorders: a systematic review. Sleep Medicine Reviews, 56, 101408. https://doi.org/10.1016/j.smrv.2021.101408
10. 10.Morin, C. M., Belleville, G., Bélanger, L., & Ivers, H. (2011). The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep, 34(5), 601-608. https://doi.org/10.1093/sleep/34.5.601
11. 11.Nuritas Ltd. (2024). A Randomized, Double-Blind, Placebo-Controlled, 6-Week Decentralised Trial Evaluating the Effects of PeptiSleep on Sleep Quality in Healthy Adults. ClinicalTrials.gov. NCT07258433. https://clinicaltrials.gov/study/NCT07258433
12. 12.Parrott, A. C., & Hindmarch, I. (1980). The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology, 71(2), 173-179. https://doi.org/10.1007/BF00427267