Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol

Insomnia Clinical Trial

— SLEEP-EX2  

Official title:

Avaliação do Smartwatch SAMSUNG no Monitoramento da Qualidade do Sono: Estudo clínico Observacional e Prospectivo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363656
• Other study ID #: 76455623.5.0000.0068
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: University of Sao Paulo General Hospital
• Contact: ARO-InCor Academic Research Organization Office
• Phone: +55 11 2661-5795
• Email: aro[@]incor.usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

Description:

Participants will answer questionnaires about overall health status, sleep quality and insomnia at the beginning, at 16 days follow-up, and at the end of the study. Participants must use the smartwatch for at least a 12-hour period that includes night time, during a minimum of 30 consecutive days.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Health Status
• Insomnia
• Sleep
• Sleep Initiation and Maintenance Disorders
• Wearable Electronic Devices

Intervention

Device:
• Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires
Synchronization of smartwatch with smartphone (internet connection) to send sleep characteristics captured by the application Weight Height Body measurements (circumferences) Questionnaires about overall health status Pittsburgh Sleep Quality Index questionnaire Insomnia Severity Index Sleep Hygiene Index Epworth Sleepiness Scale NoSAS score (Neck, Obesity, Snoring, Age, Sex)

Locations

Country	Name	City	State
Brazil	Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	São Paulo

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

Allen J. Photoplethysmography and its application in clinical physiological measurement. Physiol Meas. 2007 Mar;28(3):R1-39. doi: 10.1088/0967-3334/28/3/R01. Epub 2007 Feb 20. — View Citation

Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9. — View Citation

Bertolazi AN, Fagondes SC, Hoff LS, Pedro VD, Menna Barreto SS, Johns MW. Portuguese-language version of the Epworth sleepiness scale: validation for use in Brazil. J Bras Pneumol. 2009 Sep;35(9):877-83. doi: 10.1590/s1806-37132009000900009. English, Portuguese. — View Citation

Castro LS. Adaptação e validação do Índice de Gravidade de Insônia (IGI): Caracterização Populacional, Valores Normativos e Aspectos Associados 2011 [Available from: http://repositorio.unifesp.br/handle/11600/23193.

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

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9. — View Citation

Kasai T, Floras JS, Bradley TD. Sleep apnea and cardiovascular disease: a bidirectional relationship. Circulation. 2012 Sep 18;126(12):1495-510. doi: 10.1161/CIRCULATIONAHA.111.070813. No abstract available. — View Citation

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

Massoomi MR, Handberg EM. Increasing and Evolving Role of Smart Devices in Modern Medicine. Eur Cardiol. 2019 Dec 18;14(3):181-186. doi: 10.15420/ecr.2019.02. eCollection 2019 Dec. — View Citation

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

Outcome

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).