Insomnia Clinical Trial
— SLEEP-EX2Official title:
Avaliação do Smartwatch SAMSUNG no Monitoramento da Qualidade do Sono: Estudo clínico Observacional e Prospectivo
The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality. The main question it aims to answer is: - Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?
Status | Recruiting |
Enrollment | 158 |
Est. completion date | July 30, 2024 |
Est. primary completion date | May 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Adults (30 years old or more); - Minimum score of 7 on Pittsburgh Sleep Quality Index; - Capable of giving consent. Exclusion Criteria: - Night shift workers; - Skin condition that may interfere with optic sensor readings - such as Lupus, Atopic Dermatitis, Vitiligo; - Tattoo on the wrist area that may interfere with optic sensor readings; - Allergies or sensitivities to the components/materials of the smartwatch; - Health condition that may be considered risky/unsafe by the medical team; - Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, Samsung Eletrônica da Amazônia Ltda |
Brazil,
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Coutinho Costa J, Rebelo-Marques A, Machado JN, Gama JMR, Santos C, Teixeira F, Moita J. Validation of NoSAS (Neck, Obesity, Snoring, Age, Sex) score as a screening tool for obstructive sleep apnea: Analysis in a sleep clinic. Pulmonology. 2019 Sep-Oct;25(5):263-270. doi: 10.1016/j.pulmoe.2019.04.004. Epub 2019 Jun 10. — View Citation
Fonseca P, Weysen T, Goelema MS, Most EIS, Radha M, Lunsingh Scheurleer C, van den Heuvel L, Aarts RM. Validation of Photoplethysmography-Based Sleep Staging Compared With Polysomnography in Healthy Middle-Aged Adults. Sleep. 2017 Jul 1;40(7). doi: 10.1093/sleep/zsx097. — View Citation
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Knutson KL, Phelan J, Paskow MJ, Roach A, Whiton K, Langer G, Hillygus DS, Mokrzycki M, Broughton WA, Chokroverty S, Lichstein KL, Weaver TE, Hirshkowitz M. The National Sleep Foundation's Sleep Health Index. Sleep Health. 2017 Aug;3(4):234-240. doi: 10.1016/j.sleh.2017.05.011. Epub 2017 Jun 20. — View Citation
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Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183. — View Citation
Tonon AC, Amando GR, Carissimi A, Freitas JJ, Xavier NB, Caumo GH, Silva LG, de Souza DOG, Hidalgo MP. The Brazilian-Portuguese version of the Sleep Hygiene Index (SHI): validity, reliability and association with depressive symptoms and sleep-related outcomes. Sleep Sci. 2020 Jan-Mar;13(1):37-48. doi: 10.5935/1984-0063.20190130. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance between the smartwatch application and clinical assessment | Intraclass correlation coefficient calculated between sleep characteristics captured by the smartwatch and scores of all questionnaires | 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end). |
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