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

Not Applicable

Active, not recruiting

• Conditions: Attention Deficit Hyperactivity Disorder; Sleep Disturbance
• Interventions: Behavioral: Power Down manipulation

• Registration Number: NCT06406309
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Study Start: 2024-11-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Settle down to sleep	Power Down manipulation	All participants will engage in a 2 week home-based baseline measurement, 1 lab visit for training and measurement, and 2 week intervention trial.

Primary Outcome Measures

Name	Time	Method
General Sensory over-responsivity	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	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	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	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.
Intervention Acceptability	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.
Daily bedtime emotion dysregulation	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	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	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 Appropriateness	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.

Secondary Outcome Measures

Name	Time	Method
Change in sleep related impairment	Baseline and after 2 week intervention	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.
Circadian preference	Baseline	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)
Change in sleep difficulties	Daily across 2 weeks	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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States