RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: Non-adaptive Floreo VR control for Attention Deficit Hyperactivity Disorder

Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions.

Official registry: https://clinicaltrials.gov/study/NCT05608434 · National Institute of Mental Health (NIMH) · enrollment listed as 219

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Non-adaptive Floreo VR control, or Floreo Virtual Reality application. The registry lists allocation as randomized. Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems.

They plan to enroll about 219 people at Bethesda. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial

Interventions: Non-adaptive Floreo VR control, Floreo Virtual Reality application

Primary outcome (registry wording): ADHD-RS-5 inattention sub-scale.

Who it is for (from inclusion criteria)

Ages 8 Years to 16 Years
In order to be eligible to participate, an individual must meet all of the following criteria:
Any sex assigned at birth, or race/ethnicity
Aged between 8 and 16 years of age, including all months leading up to age 17. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age 17)
A score of \>12 on the ADHD-RS-5 inattention subscale at the screening/baseline assessment. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication) symptom levels
Stated willingness to comply with all study procedures and lifestyle considerations, availability for the duration of the study, and ability to travel to the NIH Clinical Center for the scheduled in-person study visits

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders
Impairments in uncorrected visual acuity that would interfere with engagement with the VR training
Known to be pregnant
Considered a suicide risk as determined during the clinical interview at baseline
Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable)
Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD

Public study contact (from the registry)

Saadia A Choudhury

(301) 437-0489

saadia.choudhury@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05608434 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05608434?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05608434?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary