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

NCT06363656 | Completed DMC

• 1 other identifier: 76455623.5.0000.0068
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

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

Keywords

Wearable Electronic Devices; Insomnia; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

single-group

Participants who declare having problems with sleeping/insomnia

Device: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires

Interventions

Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires DEVICE

* 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)

single-group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any participant that reports sleep problems or insomnia screened by the open survey sent to different groups in the city of Sao Paulo (Brazil).

You may qualify if:

• Adults (30 years old or more);
• Minimum score of 7 on Pittsburgh Sleep Quality Index;
• Capable of giving consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

Location

Related Publications (12)

• 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.

  PMID: 31933689 BACKGROUND

• 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.

  PMID: 28709508 BACKGROUND

• 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.

  PMID: 22988046 BACKGROUND

• 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.

  PMID: 17322588 BACKGROUND

• 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.

  PMID: 31722151 BACKGROUND

• 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.

  PMID: 28838130 BACKGROUND

• 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.

  PMID: 21145786 BACKGROUND

• 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.

  PMID: 32670491 BACKGROUND

• 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.

  PMID: 19820814 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31196834 BACKGROUND

• 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.

  PMID: 31078660 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Geraldo Lorenzi Filho, MD, PhD

  Sleep Laboratory, Instituto do Coração, Hospital das Clínicas HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of the Sleep Laboratory, Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: February 15, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

BR (1)