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Efficacy of the Apollo System for Children With ADHD

24. mars 2022 oppdatert av: Matthew B. Pontifex, Ph.D., Michigan State University

Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD

To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Matthew B Pontifex, PhD
  • Telefonnummer: 517-432-5105
  • E-post: pontifex@msu.edu

Studiesteder

  • Forente stater
    • Michigan
      • East Lansing, Michigan, Forente stater, 48824
        • Rekruttering
        • Department of Kinesiology
        • Ta kontakt med:
          • Matthew B Pontifex, Ph.D.
          • Telefonnummer: 517-432-5105
          • E-post: pontifex@msu.edu
        • Hovedetterforsker:
          • Matthew B Pontifex, Ph.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria: All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:

  1. Participants must be 8 years of age or older and under the age of 18.
  2. Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
  3. Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
  4. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria: The following exclusion criteria exist for all participants:

  1. Lack of consent.
  2. Participants cannot have started a new treatment within the last 30 days.
  3. Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.
  4. Participants cannot have previously used the Apollo System.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Commercial Apollo System Device
The active experimental group received the commercial Apollo System device.
Enhet: 8 weeks of home based use.
Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.
Sham-komparator: Sham Apollo System Device
The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.
Enhet: 8 weeks of home based use.
Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
Tidsramme: Prior to and following the 8 week study protocol period.
At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.
Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Interference Control
Tidsramme: Prior to and following the 8 week study protocol period.

At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome.

Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Response Inhibition
Tidsramme: Prior to and following the 8 week study protocol period.

At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome.

Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Prior to and following the 8 week study protocol period.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Michigan State University

Samarbeidspartnere

The Board of Medicine

Etterforskere

  • Hovedetterforsker: Matthew B Pontifex, PhD., Michigan State University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. mars 2022

Primær fullføring (Forventet)

15. august 2024

Studiet fullført (Forventet)

15. august 2024

Datoer for studieregistrering

Først innsendt

24. mars 2022

Først innsendt som oppfylte QC-kriteriene

24. mars 2022

Først lagt ut (Faktiske)

4. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00005951

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.

IPD-delingstidsramme

Data will be available following primary publication of the results.

Tilgangskriterier for IPD-deling

By request and completion of an institutional data-safety and sharing agreement.

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Informert samtykkeskjema (ICF)
  • Analytisk kode

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

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Forhold

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