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

NCT ID: NCT06406309

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-07-31

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.

Conditions

Attention Deficit Hyperactivity Disorder; Sleep Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Settle down to sleep

All participants will engage in a 1 week home-based baseline measurement, 1 lab visit for training and measurement, and 2 week intervention trial.

Group Type: EXPERIMENTAL

Power Down manipulation

Intervention Type: 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.

Interventions

Power Down manipulation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Klingenstein Third Generation Foundation

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Amy Hartman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy G Hartman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY24030096

Identifier Type: -

Identifier Source: org_study_id