Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
13 août 2026 mis à jour par: Virginia Commonwealth University
Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior
This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB).
Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
who engage in self-injurious behavior (SIB).
Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support.
Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self-injurious and repetitive behaviors during the study period.
This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.
Type d'étude
Interventionnel
Inscription (Estimé)
18
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Laura Lee Robins
- Numéro de téléphone: (757) 285-3486
- E-mail: robinslp@vcu.edu
Lieux d'étude
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth Uniersity
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Contact:
- Laura Robins
- Numéro de téléphone: 757-541-8460
- E-mail: robinslp@vcu.edu
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Chercheur principal:
- Stacey Reynolds
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria for child:
- Diagnosis of autism spectrum disorder (ASD), as reported by caregiver
- Presence of self-injurious behavior, as reported by caregiver
- Demonstrates sensory over and/or under- responsivity
- Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment
- Has a caregiver willing and able to provide consent and participate in study procedures
Exclusion Criteria for child:
Has medical condition that may increase risk with use of a wearable nibrotactile device, including:
- implanted medical or neurological devices (e.g., pacemaker)
- significant cardiac conditions or arrhythmias
- history of syncope (fainting)
- Known seizure disorder without physician clearance
- Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days
- Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures
Inclusion Criteria for Caregiver:
- Parent or legal guardian of the enrolled child participant
- Able to provide informed consent in English
- Able and willing to support device use according to study protocol and complete study-related data collection
- Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period
Exclusion Criteria for Caregiver:
• Unable to provide informed consent in English
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Apollo Neuro device
Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity.
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Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol.
The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence to wearing the Apollo Neuro Wearable
Délai: 30-35 days
|
Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention.
Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
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30-35 days
|
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Acceptability of Intervention Measure (AIM)
Délai: 30-35 days
|
Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention.
Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
|
30-35 days
|
|
The Repetitive Behavior Scale-Revised (RBS-R)
Délai: 30-35 days
|
Caregiver-reported behaviors, as measured by the Repetitive Behavior Scale-Revised (RBS-R), a validated 43-item questionnaire assessing the presence and severity of restricted and repetitive behaviors in individuals with autism spectrum disorder, including self-injurious behavior.
The measure is completed by caregivers at baseline and post-intervention using a 4-point Likert scale.
Scores will be summarized descriptively to characterize patterns over the study period.
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30-35 days
|
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Changes in caregiver-reported SIB intensity
Délai: 30-35 days
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Daily caregiver-reported ratings of peak self-injurious behavior intensity, measured using a visual analog scale (VAS) recorded on a study-designed data collection form.
Caregivers will provide ratings each day throughout the intervention period.
Data will be summarized descriptively to characterize variability and patterns over time.
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30-35 days
|
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Feasibility of Intervention Measure (FIM)
Délai: 30-35 days
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Caregiver-reported feasibility of the intervention, as measured by the Feasibility of Intervention Measure (FIM), a validated 4-item instrument assessing the extent to which the intervention can be successfully implemented within the home setting.
Each item is rated on a 5-point Likert scale ranging from 1(Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
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30-35 days
|
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Change in intensity of self-injurious behavior
Délai: 30-35 days
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Changes in the intensity of self-injurious behavior associated with the use of the Apollo Neuro wearable device will be measured by caregiver-reported tracking daily ratings of peak self-injurious behavior intensity on a study designed form tracking the participant adherence.
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30-35 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Stacey Reynolds, Virginia Commonwealth University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
1 novembre 2027
Achèvement de l'étude (Estimé)
1 novembre 2027
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
15 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HM300001048
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
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