Sleep DeprivationSMARTCITYNCT05066581
Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement
A study testing Live Chat in people with Sleep Deprivation and Sleep Hygiene, run by Hospital Universitario Araba at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Hygiene
- What is being tested?
- Live Chat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jun 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep Deprivation, Sleep Hygiene
- Being tested
- Live Chat
- Medical subject headings
- Sleep Deprivation, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live ChatDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Philips band | No intervention | 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. |
| Philips Band + Live chat | Active comparator | 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. Receives: Device: Live Chat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start21 Jun 2021
- Primary completion29 Mar 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Araba
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, Ayuntamiento de Vitoria, Ibermatica, Bioaraba Health Research Institute
- Responsible party
- Principal investigator, Carlos Javier Egea Santaolalla,Ph, Hospital Universitario Araba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066581
- Sponsor's protocol ID
- PI21/0108
- Acronym
- SMARTCITY
- Status last verified
- Mar 2023
- First submitted
- 8 Sep 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.
- ClinicalTrials.gov ID
- NCT05066581
- Acronym / sponsor ID
- SMARTCITY / PI21/0108
- Conditions
- Sleep Deprivation, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Hospital Universitario ArabaUniversity, hospital or other
- Collaborators
- Philips Healthcare, Ayuntamiento de Vitoria, Ibermatica, Bioaraba Health Research Institute
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Philips band | No intervention | –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. |
| Philips Band + Live chat | Active comparator | Device: Live ChatIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 65 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live ChatSubjects 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 | Device | Philips Band + Live chat |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Chat in people with Sleep Deprivation and Sleep Hygiene, run by Hospital Universitario Araba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (time frame: Eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.