Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD

NCT06406309 | Active Not Recruiting

• 1 other identifier: STUDY24030096
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder; Sleep Disturbance

Keywords

Sleep disturbances; Emotion Dysregulation; Sensory Processing; ADHD

Outcome Measures

Primary Outcomes (9)

• 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)

  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).

  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).

  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.

  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).

  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.

  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.

  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.

  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.

  After 2 week intervention

Secondary Outcomes (3)

• Circadian preference

  Baseline

• Change in sleep difficulties

  Daily across 2 weeks

• Change in sleep related impairment

  Baseline and after 2 week intervention

Study Arms (1)

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.

Behavioral: Power Down manipulation

Interventions

Power Down manipulation BEHAVIORAL

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.

Settle down to sleep

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Klingenstein Third Generation Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Amy G Hartman, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Micro-longitudinal (3 weeks total, daily measurement) observational baseline (1 week) and 2 week intervention study trialing a bedtime manipulation intervention.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 9, 2024
• Study Start: November 1, 2024
• Primary Completion: June 20, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available to share after publication of findings or 2 years after the end of the study, whichever comes first.
• Access Criteria: Data will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions.

Locations

US (1)