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InsomniaSLEEP-EX2NCT06363656

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

An observational study of Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
What is being tested?
Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires
Type of treatment
Medical device
How many people
158 participants
Where
1 siteBrazil
Study dates
15 Feb 2024to 28 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    São Paulo, 05403-900

Other trials in Brazil

About this study

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?
Read the detailed 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.

Being tested
Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires
Keywords
Wearable Electronic Devices, Insomnia, Sleep Quality
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionairesDevice

    • 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)
Study groups in NCT06363656
Study groupRoleWhat they receive
single-groupParticipants who declare having problems with sleeping/insomnia
Receives: Device: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start15 Feb 2024
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06363656
Sponsor's protocol ID
76455623.5.0000.0068
Acronym
SLEEP-EX2
Status last verified
Aug 2024
First submitted
8 Apr 2024
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31933689

  • 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.

    PubMed 28709508

  • 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.

    PubMed 22988046

  • 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.

    PubMed 17322588

  • 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.

    PubMed 31722151

  • 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.

    PubMed 28838130

  • 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.

    PubMed 21145786

  • 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.

    PubMed 32670491

  • 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.

    PubMed 19820814

  • 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.

    PubMed 31196834

  • 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.

    PubMed 31078660

Questions about this trial

What is this clinical trial studying?

An observational study of Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance between the smartwatch application and clinical assessment (time frame: 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06363656, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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