Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement (SMARTCITY)

Hospital Universitario Araba

Status: Completed

Conditions: Sleep Deprivation; Sleep Hygiene

Treatments: Device: Live Chat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05066581

PI21/0108

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 65 years

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups

Philips band

No Intervention group

Description:

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.

Philips Band + Live chat

Active Comparator group

Description:

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.

Treatment:

Device: Live Chat