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

Primary Purpose

Sleep Deprivation, Sleep Hygiene

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Live Chat
Sponsored by
Hospital Universitario Araba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Deprivation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Hospital Universitario Alava

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Philips band

Philips Band + Live chat

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
March 31, 2023
Sponsor
Hospital Universitario Araba
Collaborators
Philips Healthcare, Ayuntamiento de Vitoria, Ibermatica, Bioaraba
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1. Study Identification

Unique Protocol Identification Number
NCT05066581
Brief Title
Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement
Acronym
SMARTCITY
Official Title
Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Araba
Collaborators
Philips Healthcare, Ayuntamiento de Vitoria, Ibermatica, Bioaraba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Sleep Hygiene

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Philips band
Arm Type
No Intervention
Arm 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.
Arm Title
Philips Band + Live chat
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Live Chat
Intervention Description
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 Outcome Measure Information:
Title
Total sleep time
Description
By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.
Time Frame
Eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Alava
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

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