Attention Deficit Hyperactivity DisorderNCT06406309
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
A study testing Power Down manipulation in people with Attention Deficit Hyperactivity Disorder and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Sleep Disturbance
- What is being tested?
- Power Down manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 13 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Settling Down for Sleep: The Impact of Sensory and Arousal Systems on Sleep in ADHD
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.
Read the detailed description
Following the consent process, baseline data collection will be completed electronically with questionnaires sent digitally to participants (parent and child) using a secure, web-based application (REDCap). Participants will then complete a virtual clinical baseline interview and training on the wear of the EmbracePlus ("watch") and the daily virtual sleep diary. Upon completion of this, the study team will then send the watch and its accessories to the participant via the mail.
Time point 1 home-based data collection (1 week): Once the caregiver and child receive the watch and study materials, home-based data collection will start. During this 1-week period, the child will wear the watch 24-hours/day for one week and the caregiver(s) will complete daily sleep diary entries (morning and evening). At the end of this data collection period, the study materials will be brought into the lab session.
Lab-based session (1-2 hours): Participants and caregivers will complete a training session on the environmental changes and a novel bedtime manipulation intervention called the "Power Down".
Time point 2 home-based data collection (2 weeks): Participants will apply any sleep environment changes identified during the lab session, complete the 'power down" each night, child will wear the watch 24hrs/day, and caregivers will complete daily sleep diaries (morning and evening). At the end of this timepoint, all study materials will be mailed back to the study team and a virtual exit interview will be completed. Final sleep and intervention acceptability questionnaires will be completed virtually.
- Being tested
- Power Down manipulation
- Keywords
- Sleep disturbances, Emotion Dysregulation, Sensory Processing, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Down manipulationBehavioural
The Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for children with ADHD). The Power Down incorporates sensory-based tools (gentle tactile pressure and auditory cues) to support nervous system regulation prior to attempting sleep onset. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep during the 2-week intervention phase. The child will also wear a watch-like activity monitor (ActiGraph GT9x) for the 2 week period throughout the day and night to measure changes in sleep and activity patterns. Caregivers will complete daily diary questions in the morning and evening reporting their child's emotions and sleep timing.
| Study group | Role | What they receive |
|---|---|---|
| Settle down to sleep | Experimental | All participants will engage in a 1 week home-based baseline measurement, 1 lab visit for training and measurement, and 2 week intervention trial. Receives: Behavioral: Power Down manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Sensory over-responsivity
Caregiver-reported Sensory Profile-2 questionnaire: Sensitivity sub scale score (score range of 0 - 95, with higher numbers indicating more frequent endorsement)
Measured: Baseline
General bedtime arousal
Pre-Sleep Arousal Scale total score (range of 16-80): caregiver- and child-reported arousal experiences prior to bedtime. Likert scale (1-5, with 1 indicating that the person does not experience the symptom at all and 5 indicating that a person experiences the symptom extremely).
Measured: Baseline
General Emotion dysregulation
Emotion Dysregulation Inventory Short Form: Reactivity and Dysphoria total scores: Caregiver-reported questionnaire scored on a Likert scale from 1 ("Not at all") to 5 (Very Severe"). Reactivity sub scale is a total of 8 questions (range of 8-40) and dysphoria sub scale is a total of 5 questions (range of 5-25).
Measured: Baseline
Daily bedtime arousal level
The Empatica Embrace Plus is a watch-like device that captures movement and electrodermal activity during wear. The child will wear the Empatica all day and night for 2 weeks. The bedtime period will be isolated and measures of movement (maximum magnitude of activity using accelerometery) and electrodermal activity (maximum skin conductance levels) will be extracted to assess bedtime arousal level nightly.
Measured: Daily for 2 weeks
Daily bedtime emotion dysregulation
Emotion Dysregulation Inventory Short Form Reactivity and Dysphoria sub scales: Caregiver-reported questionnaire scored on a Likert scale from 1 ("Not at all") to 5 (Very Severe"). Reactivity sub scale is a total of 8 questions (range of 8-40) and dysphoria sub scale is a total of 5 questions (range of 5-25).
Measured: Daily for 2 weeks
Change in sleep disturbances
Change in PROMIS Sleep Disturbances Scale: Caregiver reported outcome with 15 questions on a Likert scale of 1 ("Never") to 5 ("Always"). Scoring ranges from 15 - 75. Baseline and post intervention total scores will be examined to measure change in sleep disturbances across time.
Measured: Baseline and after 2 week intervention
Intervention Feasibility
Feasibility of Intervention Measure (FIM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
Measured: After 2 week intervention
Intervention Acceptability
Acceptability of Intervention Measure (AIM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
Measured: After 2 week intervention
Intervention Appropriateness
Intervention Appropriateness Measure (IAM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
Measured: After 2 week intervention
Secondary outcomes (3)
Circadian preference
Morningness and Eveningness Questionnaire: Child-reported questionnaire with 10 multiple choice questions scored on a scale of 1 to 4 or 5 with a higher score indicating a stronger morning preference and a lower score indicating minimal morning preference (range of score is 10 - 42)
Measured: Baseline
Change in sleep difficulties
Using the actigraphy data and data from daily diaries, we will calculate sleep onset latency each night of baseline (1 week) and across the 1 week of intervention trial
Measured: Daily across 2 weeks
Change in sleep related impairment
Change in total score of the PROMIS Sleep Related Impairment Scale: Caregiver reported outcome with 4 questions on a Likert scale of 1 ("Never") to 5 ("Always"). Scoring ranges from 4-20. Total score will be collected at baseline and post intervention and change scores will be calculated.
Measured: Baseline and after 2 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2025
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Micro-longitudinal (3 weeks total, daily measurement) observational baseline (1 week) and 2 week intervention study trialing a bedtime manipulation intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation
- Responsible party
- Principal investigator, Amy Hartman, University of Pittsburgh
- Investigators
- Amy G Hartman, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406309
- Sponsor's protocol ID
- STUDY24030096
- Status last verified
- Aug 2026
- First submitted
- 1 May 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Settling Down for Sleep: The Impact of Sensory and Arousal Systems on Sleep in ADHD
- ClinicalTrials.gov ID
- NCT06406309
- Acronym / sponsor ID
- STUDY24030096
- Keywords
- Sleep disturbances, Emotion Dysregulation, Sensory Processing, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following the consent process, baseline data collection will be completed electronically with questionnaires sent digitally to participants (parent and child) using a secure, web-based application (REDCap). Participants will then complete a virtual clinical baseline interview and training on the wear of the EmbracePlus ("watch") and the daily virtual sleep diary. Upon completion of this, the study team will then send the watch and its accessories to the participant via the mail.
Time point 1 home-based data collection (1 week): Once the caregiver and child receive the watch and study materials, home-based data collection will start. During this 1-week period, the child will wear the watch 24-hours/day for one week and the caregiver(s) will complete daily sleep diary entries (morning and evening). At the end of this data collection period, the study materials will be brought into the lab session.
Lab-based session (1-2 hours): Participants and caregivers will complete a training session on the environmental changes and a novel bedtime manipulation intervention called the "Power Down".
Time point 2 home-based data collection (2 weeks): Participants will apply any sleep environment changes identified during the lab session, complete the 'power down" each night, child will wear the watch 24hrs/day, and caregivers will complete daily sleep diaries (morning and evening). At the end of this timepoint, all study materials will be mailed back to the study team and a virtual exit interview will be completed. Final sleep and intervention acceptability questionnaires will be completed virtually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Micro-longitudinal (3 weeks total, daily measurement) observational baseline (1 week) and 2 week intervention study trialing a bedtime manipulation intervention.
| Arm | Type | Receives |
|---|---|---|
| Settle down to sleep | Experimental | Behavioral: Power Down manipulationAll participants will engage in a 1 week home-based baseline measurement, 1 lab visit for training and measurement, and 2 week intervention trial. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Down manipulationThe Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for children with ADHD). The Power Down incorporates sensory-based tools (gentle tactile pressure and auditory cues) to support nervous system regulation prior to attempting sleep onset. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep during the 2-week intervention phase. The child will also wear a watch-like activity monitor (ActiGraph GT9x) for the 2 week period throughout the day and night to measure changes in sleep and activity patterns. Caregivers will complete daily diary questions in the morning and evening reporting their child's emotions and sleep timing. | Behavioural | Settle down to sleep |
Primary outcome
General Sensory over-responsivity
Time frame: Baseline
Caregiver-reported Sensory Profile-2 questionnaire: Sensitivity sub scale score (score range of 0 - 95, with higher numbers indicating more frequent endorsement)
General bedtime arousal
Time frame: Baseline
Pre-Sleep Arousal Scale total score (range of 16-80): caregiver- and child-reported arousal experiences prior to bedtime. Likert scale (1-5, with 1 indicating that the person does not experience the symptom at all and 5 indicating that a person experiences the symptom extremely).
General Emotion dysregulation
Time frame: Baseline
Emotion Dysregulation Inventory Short Form: Reactivity and Dysphoria total scores: Caregiver-reported questionnaire scored on a Likert scale from 1 ("Not at all") to 5 (Very Severe"). Reactivity sub scale is a total of 8 questions (range of 8-40) and dysphoria sub scale is a total of 5 questions (range of 5-25).
Daily bedtime arousal level
Time frame: Daily for 2 weeks
The Empatica Embrace Plus is a watch-like device that captures movement and electrodermal activity during wear. The child will wear the Empatica all day and night for 2 weeks. The bedtime period will be isolated and measures of movement (maximum magnitude of activity using accelerometery) and electrodermal activity (maximum skin conductance levels) will be extracted to assess bedtime arousal level nightly.
Daily bedtime emotion dysregulation
Time frame: Daily for 2 weeks
Emotion Dysregulation Inventory Short Form Reactivity and Dysphoria sub scales: Caregiver-reported questionnaire scored on a Likert scale from 1 ("Not at all") to 5 (Very Severe"). Reactivity sub scale is a total of 8 questions (range of 8-40) and dysphoria sub scale is a total of 5 questions (range of 5-25).
Change in sleep disturbances
Time frame: Baseline and after 2 week intervention
Change in PROMIS Sleep Disturbances Scale: Caregiver reported outcome with 15 questions on a Likert scale of 1 ("Never") to 5 ("Always"). Scoring ranges from 15 - 75. Baseline and post intervention total scores will be examined to measure change in sleep disturbances across time.
Intervention Feasibility
Time frame: After 2 week intervention
Feasibility of Intervention Measure (FIM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
Intervention Acceptability
Time frame: After 2 week intervention
Acceptability of Intervention Measure (AIM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
Intervention Appropriateness
Time frame: After 2 week intervention
Intervention Appropriateness Measure (IAM): Caregiver-reported questionnaire with 4 questions on a Likert scale of 1 ("Completely disagree") to 5 ("Completely agree"). Scoring ranges from 4-20.
3 secondary outcomes
Circadian preference
Time frame: Baseline
Change in sleep difficulties
Time frame: Daily across 2 weeks
Change in sleep related impairment
Time frame: Baseline and after 2 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy G Hartman, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Down manipulation in people with Attention Deficit Hyperactivity Disorder and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Sensory over-responsivity (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.