Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD (NCT06406309) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
United States30 participantsStarted 2024-11-01
Plain-language summary
The goal of this study is test the hypothesis that sleep problems for children with ADHD are linked to sensory over-responsivity, a type of sensory processing difference that causes a person to interpret daily sensory input as stressful. This study examines the impact of sensory over-responsivity on bedtime arousal levels in 30 children with ADHD (ages 6-13). We will also test a bedtime intervention targeting sensory over-responsivity at bedtime and examine how it impacts bedtime arousal levels and sleep difficulties.
Who can participate
Age range
6 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child aged 6-13 years
* A reported clinical diagnosis of ADHD or suspected ADHD and 6+ items endorsed as "quite a bit" or "very much" a single domain on SNAP-IV (ADHD symptomology questionnaire)
* Parents endorse \>20 minutes to settle down and fall asleep
* Caregiver willing to participate in all bedtimes during intervention.
* Willing to come into the lab in Pittsburgh
Exclusion Criteria:
* Concurrent organic sleep disorder (sleep apnea, narcolepsy), psychiatric (major depression, bipolar, OCD, psychosis, schizophrenia)
* Current behavioral treatment for sleep disorder
* Unstable ADHD medication use (dose or timing)
* Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
* If a child spends bedtime at a different caregiver's home for \>50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.