Clinical trial NCT06406309: Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
Official title: Settling Down for Sleep: The Impact of Sensory and Arousal Systems on Sleep in ADHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sleep Disturbance
Keywords: Sleep disturbances
Emotion Dysregulation
Sensory Processing
ADHD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2024-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Micro-longitudinal (3 weeks total, daily measurement) observational baseline (1 week) and 2 week intervention study trialing a bedtime manipulation intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: General Sensory over-responsivity
timeFrame: Baseline
measure: General bedtime arousal
timeFrame: Baseline
measure: General Emotion dysregulation
timeFrame: Baseline
measure: Daily bedtime arousal level
timeFrame: Daily for 2 weeks
measure: Daily bedtime emotion dysregulation
timeFrame: Daily for 2 weeks
measure: Change in sleep disturbances
timeFrame: Baseline and after 2 week intervention
measure: Intervention Feasibility
timeFrame: After 2 week intervention
measure: Intervention Acceptability
timeFrame: After 2 week intervention
measure: Intervention Appropriateness
timeFrame: After 2 week intervention
Secondary outcomes:
measure: Circadian preference
timeFrame: Baseline
measure: Change in sleep difficulties
timeFrame: Daily across 2 weeks
measure: Change in sleep related impairment
timeFrame: Baseline and after 2 week intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amy G Hartman, PhD
role: PRINCIPAL_INVESTIGATOR
References: