ADHD Trial, Recruiting NCT06410495 Sponsor: University of South Florida Condition: ADHD
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ADHD Trial, Recruiting

NCT06410495
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 8 to 17 who have already been diagnosed with Oppositional Defiant Disorder (ODD) and also have trouble sleeping
  • Both the child and their parent or guardian are able to communicate in English
  • The child has had problems falling asleep, staying asleep, or waking up too early, for 3 months or more — either as reported by the child or noticed by a parent
  • The child's sleep problems are causing difficulties during the day, such as changes in mood, thinking, socialising, or school performance
  • Sleep tracking records (diaries and a wrist-worn monitor) show the child is spending more than 30 minutes falling asleep, awake during the night, or waking too early, on at least 6 nights

Who may not be able to join:

  • Cases where the parent or guardian is not able to give formal consent, or the child is not able to give their own agreement to participate
  • Families who are not willing to be randomly assigned to a treatment group
  • Children or parents already taking part in another randomised research study
  • Parents who, due to cognitive difficulties, are not able to fill in forms or carry out the treatment steps involved
  • Children who have an untreated medical condition, including other sleep disorders (such as sleep apnoea or epilepsy), psychotic disorders, frequent parasomnias (such as sleepwalking), or current suicidal thoughts or intent
  • Children taking medications that affect sleep — with the exception of stimulants, sleep medications, or melatonin
  • Children already receiving a non-medication treatment for sleep (including talking therapies such as CBT) outside of this trial
  • Cases where the parent reports the child cannot wear a Holter heart monitor or wrist sleep tracker, for example due to extreme skin sensitivity or behavioural difficulties
  • Other conditions that the trial site determines would interfere with taking part (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 8123828872

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of South Florida
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
1 August 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Child Daily Sleep Diaries; Parent Daily Sleep Diaries

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov