Sleep therapy study for ADHD teens pulled before start
NCT ID NCT07209969
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study was designed to see if cognitive behavioral therapy for insomnia (CBT-I) could help teenagers with ADHD who also have trouble sleeping. It planned to enroll adolescents aged 11-18 with both ADHD and insomnia. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Apr 2023
An estimate. Start dates often move.
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Adolescents aged 11-18 years old meeting the following inclusion criteria were invited to take part in the present study: 1. Having a clinical diagnosis of ADHD made by health care professionals (psychiatrist, clinical psychologist, or educational psychologist) based on self-report; 2. a DSM-5 diagnosis of insomnia disorder, and a score on ISI ≥ 9 (suggested cut-off for adolescents) (Chung et al., 2011); 3. Those who agreed to keep the same dosage of medication throughout the study up till completion of follow up assessments. Exclusion Criteria: Adolescents were excluded if they met any of the following criteria: 1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorders, organic mental disorders, or intellectual disabilities; 2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. severe eczema, gastro-oesophageal reflux disease); 3. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, based on self-reported medical history; 4. On an optimal dosage of psychostimulant or nonstimulant ADHD medications for less than a month; 5. Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids), except for the use of psychostimulant medication for ADHD; 6. Receiving ongoing pharmacological and psychological treatment for insomnia; 7. With hearing or speech deficit.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital
Hong Kong, Hong Kong
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Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
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Other studies related to the condition(s) this trial covers.
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