Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

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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Key information

Conditions

Sleep Deprivation Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Hygiene Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Alava

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live Chat

Device

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

Primary outcomes

Total sleep time

Time frame: Eight months

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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Araba

Other

Collaborators

Ayuntamiento de Vitoria
Bioaraba Health Research Institute
Ibermatica
Philips Healthcare

Registry information

Official study title

Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.

Acronym: SMARTCITY

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 4, 2021
Registry last updated: Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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