Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

Not Applicable

Completed

• Conditions: Sleep Deprivation; Sleep Hygiene
• Interventions: Device: Live Chat

• Registration Number: NCT05066581
• Lead Sponsor: Hospital Universitario Araba

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-04
• Primary Completion: 2022-03-29
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Philips Band + Live chat	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.

Primary Outcome Measures

Name	Time	Method
Total sleep time	Eight months	By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.

Trial Locations

Locations (1)

Hospital Universitario Alava; 🇪🇸 Vitoria-gasteiz, Alava, Spain