Sensory Intervention for Sleep Issues in ADHD

Overseen By Amy G Hartman, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Sleep apnea, Narcolepsy, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether sleep problems in children with ADHD connect to sensory over-responsivity, which means being overly sensitive to everyday sensory experiences. Researchers seek to determine if addressing this sensitivity at bedtime can reduce nighttime restlessness and improve sleep. The treatment, called Power Down manipulation (a sensory intervention), involves a one-week home baseline measurement, a lab training session, and a two-week intervention. Children aged 6-13 with ADHD who struggle to fall asleep within 20 minutes might be suitable participants, and a caregiver must be willing to participate in the bedtime routine and visit the lab in Pittsburgh. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving sleep in children with ADHD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires stable ADHD medication use, meaning your dose and timing should not change.

What prior data suggests that this sensory intervention is safe for children with ADHD?

Research has shown that sensory treatments for sleep problems in children with ADHD are safe. Studies have found these treatments to be well-tolerated, with no reported negative effects. Treatments aimed at managing children's reactions to sensory input at bedtime are generally safe. Therefore, those considering joining a trial for these treatments can be reassured that current evidence suggests they are unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Power Down manipulation for sleep issues in ADHD because it offers a novel, non-pharmacological approach. Unlike traditional treatments like medication or behavioral therapy, this intervention focuses on sensory techniques to help individuals settle down for sleep. It empowers participants to manage their sleep routines at home with accessible methods, potentially minimizing side effects associated with medications. This approach could be a game-changer for those seeking alternative strategies to improve sleep without relying on drugs.

What evidence suggests that the Power Down manipulation is effective for sleep issues in ADHD?

Research shows that sensory interventions, such as those in the "Power Down" method, can improve sleep in children with ADHD. In this trial, participants will engage in a "Settle down to sleep" intervention, which includes a 1-week home-based baseline measurement, a lab visit for training and measurement, and a 2-week intervention trial. Studies have found that assisting children who are sensitive to everyday sights, sounds, or touches can reduce bedtime stress. For instance, using weighted blankets can help children fall asleep more easily. Additionally, reviews suggest that behavioral sleep techniques effectively address sleep problems in children with ADHD, enhancing both their sleep and overall quality of life. Although more research is needed, these findings offer promising support for sensory-based sleep treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Amy G Hartman, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children aged 6-10 with ADHD who have trouble settling down to sleep, taking more than 20 minutes. They must have a clinical diagnosis or show significant symptoms of ADHD and their caregiver must be involved in all bedtimes during the intervention. Participants need to visit the lab in Pittsburgh.

Inclusion Criteria

It takes my child more than 20 minutes to fall asleep.

I am willing to travel to Pittsburgh for the study.

My caregiver agrees to help with all bedtimes during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection completed electronically with questionnaires and virtual clinical baseline interview

1 week

Virtual visits for baseline interview and training

Home-based Data Collection

Participants engage in home-based data collection wearing the EmbracePlus watch and completing daily sleep diaries

1 week

Home-based, no in-person visits

Lab-based Session

Participants and caregivers complete a training session on environmental changes and the 'Power Down' intervention

1-2 hours

1 in-person lab visit

Intervention

Participants apply sleep environment changes and complete the 'Power Down' intervention each night

2 weeks

Home-based, no in-person visits

Follow-up

Participants are monitored for changes in sleep disturbances and intervention acceptability

2 weeks

Virtual exit interview and final questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Power Down manipulation

Trial Overview The study tests an intervention called 'Power Down manipulation' designed to help children with ADHD relax before bedtime by addressing sensory over-responsivity—a condition where normal sensory input causes stress—and its effect on sleep problems.

How Is the Trial Designed?

Group I: Settle down to sleep Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

The Klingenstein Third Generation Foundation

Collaborator

Trials

6

Recruited

1,400+

Published Research Related to This Trial

In a study involving eight young children with sensory over-responsivity, wearing Touchpoints™ on their ankles before bed significantly reduced the time it took for them to fall asleep (sleep latency).

Parents reported improvements in their children's overall sleep quality, although there were no significant changes in sleep duration, sleep efficiency, or number of nighttime awakenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children with Sensory over-Responsivity. McGhee, K., Kidney, E., Pou, K., et al.[2021]

Adolescents with ADHD experience significantly more sensory modulation difficulties and sleep issues compared to their peers without ADHD, highlighting the need for targeted assessments in this population.

There are strong correlations between sensory difficulties and sleep problems in adolescents with ADHD, suggesting that addressing sensory processing may improve sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationships between sensory modulation and sleep among adolescents with ADHD. Lufi, D., Tzischinsky, O.[2018]

In a study of 76 children aged 8-11, 86.4% of those with ADHD and atypical sensory profiles experienced sleep difficulties, compared to only 30.8% of those with typical sensory profiles and 16.7% of control children.

Children with ADHD and atypical sensory profiles had significantly higher odds (OR = 32.4) of experiencing sleep difficulties compared to controls, indicating a strong association between sensory modulation difficulties and sleep issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between sensory modulation and sleep difficulties in children with Attention Deficit Hyperactivity Disorder (ADHD). Mimouni-Bloch, A., Offek, H., Engel-Yeger, B., et al.[2021]

Children with ADHD experienced significantly shorter REM sleep duration and overall sleep duration compared to healthy controls, indicating distinct sleep architecture differences.

Additionally, children with ADHD reported higher levels of sleep anxiety and insufficient sleep, suggesting that sleep disturbances are a common issue in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbances in prepubertal children with attention deficit hyperactivity disorder: a home polysomnography study. Gruber, R., Xi, T., Frenette, S., et al.[2021]

In a study involving 56 schoolchildren, significant correlations were found between sleep disturbances, behavioral issues, and sensory processing, indicating that sensory hypersensitivity may play a key role in these relationships.

Tactile sensitivity was identified as a strong predictor of sleep disturbances, explaining 25% of the variance, while both sensation seeking and tactile sensitivity accounted for 42% of the variance in behavioral issues, suggesting the importance of assessing sensory profiles in children with sleep or behavioral disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory hypersensitivity as a contributing factor in the relation between sleep and behavioral disorders in normal schoolchildren. Shochat, T., Tzischinsky, O., Engel-Yeger, B.[2022]

Out of 71 randomized controlled trials (RCTs) on ADHD, only 40 used sleep as a primary outcome measure, highlighting a gap in research focus on sleep disturbances in children with ADHD.

The review found that while various tools like actigraphy and sleep questionnaires are used to measure sleep, there is a lack of standardization in these measurement methods, suggesting that sleep should be prioritized as a core outcome in future ADHD studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep as an outcome measure in ADHD randomized controlled trials: A scoping review. McWilliams, S., Zhou, T., Stockler, S., et al.[2022]

A smartphone application designed for sensory diets showed significant improvement in attention deficit symptoms among children with ADHD after two months of use by their mothers, with a notable change in scores from 13.67 to 22 (P-value<0.0001).

While the application was rated highly for usability (8.35 out of 9), improvements in impulsivity and hyperactivity were observed but not statistically significant when compared to a control group, indicating the need for further research to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a sensory diet smartphone application on the symptoms of children with attention deficit hyperactivity disorder (ADHD): A feasibility study. Khanahmadi, S., Sourtiji, H., Khanahmadi, Z., et al.[2023]

Children with tactile hypersensitivities (SS) and their non-sensitive peers (NSS) showed similar overall movement-based rest-activity rhythms and sleep period variables, but children with SS took significantly longer to fall asleep (53 minutes) compared to NSS (26 minutes).

Both groups exhibited low sleep efficiency (around 77-78%) and shorter total sleep time (approximately 7 hours 26 minutes for SS and 7 hours 33 minutes for NSS), which is below national recommendations for children's sleep duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing rest-activity rhythms and sleep for children with and without tactile sensitivities: An observational study. Hartman, AG., McKendry, S., Akcakaya, M., et al.[2023]

Parents of 24 children with ADHD reported that using weighted blankets for 16 weeks significantly improved their children's sleep quality, including faster sleep onset and better sleep routines.

The use of weighted blankets also enhanced children's overall well-being by reducing anxiety and improving their ability to participate in daily activities, suggesting a beneficial non-pharmacological intervention for sleep disturbances in ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' Experiences of Weighted Blankets' Impact on Children with Attention-Deficit/Hyperactivity Disorder (ADHD) and Sleep Problems-A Qualitative Study. Larsson, I., Aili, K., Nygren, JM., et al.[2021]

Citations

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Sensory Intervention for Sleep Issues in ADHD Research suggests that sensory interventions, like using weighted blankets, can help children with ADHD improve their sleep by making it easier to fall asleep ...

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