Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

Sleep Deprivation Clinical Trial

— SMARTCITY  

Official title:

Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05066581
• Other study ID #: PI21/0108
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Hospital Universitario Araba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 30, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Deprivation
• Sleep Hygiene

Intervention

Device:
• Live 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Alava	Vitoria-gasteiz	Alava

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitario Araba	Ayuntamiento de Vitoria, Bioaraba, Ibermatica, Philips Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time	By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.	Eight months