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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05066581
Other study ID # PI21/0108
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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