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Serious GameSMILERNCT05974917

Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders

An observational study of Serious Game and Asthma in Children, run by Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Serious Game, Asthma in Children, Children, Only
What is being tested?
Serious Game (SG)
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
1 Sep 2023to 31 Dec 2023
Phase
Observational
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 12 to 17 years
  • All sexes
  • Child

Study population: Male and female children aged 12 to 17 years. According to a computer-generated list, thirty children with controlled persistent asthma will be randomised into two groups: Asthma Group 1 and Asthma Group 2 'standard care'.

Who may be able to join

  • diagnosis of controlled asthma according to GINA recommendations (http://ginasthma.org)

Who cannot join

  • flare-ups requiring oral corticosteroids within the last four weeks
  • use of leukotriene receptor antagonists or therapy as required in the last four weeks
  • respiratory infections within the last four weeks
  • immunological, metabolic, cardiac or neurological diseases
  • obesity
  • preterm birth
Show all 9Show fewer
  • major malformations of the respiratory system
  • active smoking
  • pregnancy

Trial locations and contacts

No sites are listed yet.

Stefania La Grutta, MD contact

+39 091 680 9111

stefania.lagrutta@ift.cnr.it

About this study

Official title: Serious gaMe Come Interventi Emergenti di E-health Per i Giovani Con distuRbi neuroLogici o rEspiratori (SMILER) - Progetto@Cnr

The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function.

The SG is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes.

Read more

Participants will be subjected to SG as part of routine medical care, and researchers will study the effect of SG.

The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response to Adversity'.

Being tested
Serious Game (SG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serious Game (SG)Device

    SG which was conceived as a running game, in which an Avatar runs through the forest and overcomes obstacles through the player's performance of physical exercises.

    Children will play while watching an imaginary Avatar, who shows the right movements to perform in order to collect rewards. SG will be projected with a 4K projector and controlled by the child's movements, which will be tracked in markerless mode using Azure's Kinect sensor. SG will include an adaptive tool to enable the experience based on the child's specific motor skills.

    The dynamics of SG will be adapted by considering real motor and physiological data acquired during each SG session via a wristband. These data are necessary to keep the child in the aerobic zone (60-80% of maximum heart rate). The movements are:

    1. Side bending: Moving an obstacle to open a passage.
    2. High jump: Overcoming a low, frontal obstacle.
    3. Side lunge: Avoiding a side obstacle.
    4. Squat: Passing under a low, frontal obstacle.
Study groups in NCT05974917
Study groupRoleWhat they receive
Group 1with 'Serious Game' to support the asthma treatment plan
Receives: Device: Serious Game (SG)
Group 2without 'Serious Game' and will follow the standard treatment plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pediatric Quality of Life Inventory (PedsQL)

    Questionnaires

    Measured: 6 months

  2. Skills and Difficulties Questionnaire (SDQ-Ita)

    Measured: 6 months

Secondary outcomes (1)

  1. Conserved Transcriptional Response to Adversity (CTRA)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974917
Sponsor's protocol ID
Verbale N° 01/2023
Acronym
SMILER
Status last verified
Jul 2023
First submitted
6 Jun 2023
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uchida Y, Kitayama S, Akutsu S, Park J, Cole SW. Optimism and the conserved transcriptional response to adversity. Health Psychol. 2018 Nov;37(11):1077-1080. doi: 10.1037/hea0000675. Epub 2018 Sep 17.

    PubMed 30221968

  • Cole SW. The Conserved Transcriptional Response to Adversity. Curr Opin Behav Sci. 2019 Aug;28:31-37. doi: 10.1016/j.cobeha.2019.01.008. Epub 2019 Feb 25.

    PubMed 31592179

  • Mehl MR, Raison CL, Pace TWW, Arevalo JMG, Cole SW. Natural language indicators of differential gene regulation in the human immune system. Proc Natl Acad Sci U S A. 2017 Nov 21;114(47):12554-12559. doi: 10.1073/pnas.1707373114. Epub 2017 Nov 6.

    PubMed 29109260

  • Resztak JA, Farrell AK, Mair-Meijers H, Alazizi A, Wen X, Wildman DE, Zilioli S, Slatcher RB, Pique-Regi R, Luca F. Psychosocial experiences modulate asthma-associated genes through gene-environment interactions. Elife. 2021 Jun 18;10:e63852. doi: 10.7554/eLife.63852.

    PubMed 34142656

  • Ferrante G, Licari A, Marseglia GL, La Grutta S. Digital health interventions in children with asthma. Clin Exp Allergy. 2021 Feb;51(2):212-220. doi: 10.1111/cea.13793. Epub 2020 Dec 6.

    PubMed 33238032

  • Montalbano L, Ferrante G, Montella S, Cilluffo G, Di Marco A, Bozzetto S, Di Palmo E, Licari A, Leonardi L, Caldarelli V, Ghezzi M, La Grutta S, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) Program of Italian Paediatric Respiratory Society (IPRS). Relationship between quality of life and behavioural disorders in children with persistent asthma: a Multiple Indicators Multiple Causes (MIMIC) model. Sci Rep. 2020 Apr 24;10(1):6957. doi: 10.1038/s41598-020-62264-9.

    PubMed 32332757

  • Montalbano L, Cilluffo G, Gentile M, Ferrante G, Malizia V, Cibella F, Viegi G, Passalacqua G, La Grutta S. Development of a nomogram to estimate the quality of life in asthmatic children using the Childhood Asthma Control Test. Pediatr Allergy Immunol. 2016 Aug;27(5):514-20. doi: 10.1111/pai.12571. Epub 2016 May 6.

    PubMed 27018497

  • Montella S, Baraldi E, Cazzato S, Aralla R, Berardi M, Brunetti LM, Cardinale F, Cutrera R, de Benedictis FM, di Palmo E, Di Pillo S, Fenu G, La Grutta S, Lombardi E, Piacentini G, Santamaria F, Ullmann N, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) on behalf of the Italian Society of Pediatric Respiratory Diseases (SIMRI). Severe asthma features in children: a case-control online survey. Ital J Pediatr. 2016 Jan 22;42:9. doi: 10.1186/s13052-016-0217-z.

    PubMed 26796331

  • Ferrante G, La Grutta S. The Burden of Pediatric Asthma. Front Pediatr. 2018 Jun 22;6:186. doi: 10.3389/fped.2018.00186. eCollection 2018.

    PubMed 29988370

  • Waltz E. First video game to treat disease gains FDA okay. Nat Biotechnol. 2020 Nov;38(11):1224-1225. doi: 10.1038/s41587-020-0726-6. No abstract available.

    PubMed 33144726

  • Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.

    PubMed 29324745

  • Licari A, Ferrante G, Marseglia Md GL, Corsello Md G, La Grutta S. What Is the Impact of Innovative Electronic Health Interventions in Improving Treatment Adherence in Asthma? The Pediatric Perspective. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2574-2579. doi: 10.1016/j.jaip.2019.08.008. Epub 2019 Aug 16.

    PubMed 31425835

Questions about this trial

What is this clinical trial studying?

An observational study of Serious Game and Asthma in Children, run by Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR).

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 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefania La Grutta, MD (+39 091 680 9111, stefania.lagrutta@ift.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Quality of Life Inventory (PedsQL) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974917, which also lists 12 linked publications.

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 Aug 2023.

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