Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
2026年8月13日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
18
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Laura Lee Robins
- 電話番号：(757) 285-3486
- メール：robinslp@vcu.edu
研究場所
-
-
Virginia
-
Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth Uniersity
-
コンタクト：
- Laura Robins
- 電話番号：757-541-8460
- メール：robinslp@vcu.edu
-
主任研究者：
- Stacey Reynolds
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to wearing the Apollo Neuro Wearable
時間枠：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
|
|
Acceptability of Intervention Measure (AIM)
時間枠：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)
時間枠：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.
|
30-35 days
|
|
Changes in caregiver-reported SIB intensity
時間枠：30-35 days
|
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.
|
30-35 days
|
|
Feasibility of Intervention Measure (FIM)
時間枠：30-35 days
|
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.
|
30-35 days
|
|
Change in intensity of self-injurious behavior
時間枠：30-35 days
|
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.
|
30-35 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Stacey Reynolds、Virginia Commonwealth University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年12月1日
一次修了 (推定)
2027年11月1日
研究の完了 (推定)
2027年11月1日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HM300001048
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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