Sleep Disorders Trial, Recruiting NCT07091149 Sponsor: University of South Florida Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07091149
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 6 to 12 years old
  • Children with a verbal reasoning score above 70, indicating enough verbal ability to take part in treatment sessions
  • Children who have a parent or legal guardian living in the same home who is also willing to take part
  • Children who have been diagnosed with insomnia
  • Children who have had trouble sleeping for 3 or more months, including difficulty falling asleep, staying asleep, or waking too early
  • Children whose sleep problems are causing issues during the day, such as with mood, thinking, socialising, or school
  • Children who score above 8 on a standard childhood insomnia assessment tool (confirm with trial site)
  • Children and caregivers who are willing to be randomly assigned to a treatment group
  • Caregivers who are able to read and understand English at approximately a primary school level

Who may not be able to join:

  • Children who are not able to give their agreement to take part in the study
  • Children who are not willing to be randomly assigned to a treatment group
  • Children who are already taking part in another randomised research study
  • Children who have a cognitive impairment that would prevent them from completing forms or following treatment steps
  • Children who have an untreated medical condition alongside their insomnia, including other sleep disorders such as sleep apnoea, epilepsy, psychotic disorders, thoughts of suicide, or frequent episodes of abnormal sleep behaviours
  • Children currently taking medications that affect sleep (other than stimulants, prescribed or over-the-counter sleep medications, or melatonin — see notes below)
  • Children who have taken stimulants, sleep medications, or melatonin within the past month, unless the dose has been stable for 3 or more months (confirm with trial site)
  • Children currently receiving non-medication-based treatment for sleep problems, including talking therapies, outside of this trial
  • Children with other conditions that would interfere with taking part in the trial (confirm with trial site)
  • Caregivers who are not able to give their agreement to take part
  • Caregivers who are not willing to be randomly assigned to a treatment group
  • Caregivers who are already taking part in another randomised research study
  • Caregivers who have a cognitive impairment that would prevent them from completing forms or following treatment steps
  • Caregivers who are currently receiving non-medication-based treatment for sleep problems outside of this trial

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 21 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: 813-974-1804

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
10 April 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Electronic Sleep Diaries - Child; Actigraphy - Child; Session Completion; Treatment Adherence; Internet Intervention Utility Questionnaire (IIUQ); Treatment Satisfaction Survey; Pediatric Insomnia Severity Index

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: 21 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