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CompletedNCT05066581SMARTCITYUpdated Apr 3, 2023

Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

An interventional study of Live Chat in Sleep Deprivation and Sleep Hygiene, sponsored by Hospital Universitario Araba. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Hospital Universitario Araba · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Currently, the investigators know that there is a high and increasing prevalence of sleep quality and quantity deficits in the general population with the social and health consequences that this entails. There are numerous activity wristbands linked to mobile apps that analyze sleep, but none can generate individualized recommendations for improvement interacting with the person. The main objective of the current project is to develop a virtual and interactive sleep assistant to increase the quantity and quality of sleep. Secondary objectives being the improvement of daytime sleepiness and the quality of life of the persons.

Methodology: 202 participants in active employment who meet the criteria of "poor sleepers" (defined by a Pittsburg test score >5) are divided into 2 study groups. 1. Intervention group: Sleep data will be collected using validated questionnaires (SATED and the Sleep Hygiene Index) and objectively employing an activity bracelet, in which weekly, through a live chat, the medical staff of the sleep units will offer recommendations for the improvement of the deficits detected. 2. Control group: Same protocol as the intervention group, but the participants will not receive the recommendations via the interactive chat.

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Conditions studied

  • Sleep Deprivation
  • Sleep Hygiene
03

In context

Sleep Deprivation

314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.

This study's enrollment of 202 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

Hospital Universitario Araba is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 to 65 years

Exclusion criteria

Exclusion Criteria:

  • Patients previously diagnosed and treated for sleep pathology (such as insomnia, Obstructive Sleep Apnea (OSA), Restless Legs Syndrome (RLS), narcolepsy or parasomnia, among others).
  • Severe medical or psychiatric comorbidities.
  • Subjects who are not capable of using mobile technology such as Smartphone.
  • Subjects who are not committed to actively participate, putting into practice the sleep recommendations given by the assistant.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
202 participants (actual)

Study arms

  • No intervention
    Philips band

    It is a medical device that collects, among other things, movement data by means of an accelerometer, from which it accelerometer, from which it estimates the total time of sleep (TTS) and wakefulness, and waking time, also offering the efficiency of the same (time asleep in relation to time in bed). time in bed). In addition, it collects data not related to sleep, such as energy expenditure (in kilocalories), energy expenditure (in kilocalories) (in kilocalories), heart rate, and daily activity (in steps), among others.

  • Active comparator
    Philips Band + Live chat

    In the Intervention group, in addition to having the philips band, the subjects will interact through the live chat system that they will have to download to their mobile phones. This live chat offers the possibility to consult in real time, thus initiating a process of relationship between researcher/subject.

    Device: Live Chat

Interventions

  • DeviceLive Chat

    Subjects from the intervention group will be able to ask for a medical intervention if needed with the phisycians from the sleep unit. After the following period, we expect to see better sleep habits in this group when compared to the no intervention one

06

What researchers measure

Primary outcomes

  1. Total sleep time

    By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.

    Time frame: Eight months

07

Study locations

1 site
  • Hospital Universitario Alava
    Vitoria-gasteiz, Alava 01009, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05066581
Lead sponsor
Hospital Universitario Araba
Collaborators
Philips Healthcare, Ayuntamiento de Vitoria, Ibermatica, Bioaraba
Responsible party
Carlos Javier Egea Santaolalla,Ph (HEAD OF FUNCTIONAL SLEEP UNIT, Hospital Universitario Araba) — Principal investigator
First posted
Oct 4, 2021
Start date
Jun 21, 2021
Primary completion
Mar 29, 2022
Completion
Nov 30, 2022
Last update
Apr 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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