Recruiting

Sensory-Based Manipulation

Sponsor:

University of Pittsburgh

Code:

NCT07476937

Conditions

Autism

Sleep Disturbances in Children

Sleep

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Interventions

Power Down bedtime manipulation

Study Details

Brief summary:

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

Conditions

Autism

Sleep Disturbances in Children

Sleep

Study ID

NCT07476937

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Youth between the ages of 6 and 10 years old
2. Caregiver-reported autism diagnosis and >11 on Social Communication Questionnaire
3. Caregiver-reported bedtime resistance (>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)
4. Caregiver willing to participate in all bedtimes during study
5. Stable medication use (e.g., no changes within 2 weeks)

Exclusion Criteria:

1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).
2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).
3. Unstable medication use (dose or timing).
4. Current behavioral treatment for sleep disorder

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Power Down Pilot study

After consent, participants will complete an in-person lab-based sensory responsivity protocol which measures the child's responsivity to standardized sensory stimuli. Questionnaires and training on the home-based data collection protocol will also be completed. A short interview or survey regarding the lab-based protocol will be completed. After the lab visit, the child and caregiver will wear an actigraphy watch and complete daily diaries about sleep and emotion for two weeks. Upon the completion of these two weeks, the participants will return to the lab to be trained in the Power Down Protocol. Then the child and caregiver will engage in a 2-week intervention trial. Upon completion, participants will complete exit questionnaires and interviews.

no intervention: No intervention group

After consent, participants will complete an in-person lab-based sensory responsivity protocol which measures the child's responsivity to standardized sensory stimuli. Questionnaires and training on the home-based data collection protocol will also be completed. A short interview or survey regarding the lab-based protocol will be completed.

After the lab visit, the child and caregiver will wear an actigraphy watch and complete daily diaries about sleep and emotion for two weeks. Upon the completion of these two weeks, the actigraphy watches are returned and final questionnaires are completed.

Interventions

Power Down bedtime 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 autistic children). The Power Down incorporates sensory-based input (caregiver massage) to support nervous system regulation prior to attempting sleep onset. Participants (caregivers and their child) will be educated in the Power Down protocol and data collection methods for the 2 week intervention trial. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep. The child will also wear a watch-like activity monitor 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.

Primary outcome measure

  • Nightly emotion dysregulation [ Time Frame: 4 weeks ]
  • Bedtime sensory over-responsivity [ Time Frame: 4 weeks ]
  • Sleep onset latency [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Amy G Hartman, PhD

412-648-7997agh38@pitt.edu

Tracey Y Murray, BS

412-624-3961TYM2@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Amy G Hartman, PhD, OTR/L

412-648-7997agh38@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Sleep disturbances
  • Emotion Dysregulation
  • Sensory Processing
  • Sleep
  • autism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-22.