N/A
N=40
A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Autism Spectrum Disorder · Attention Deficit Hyperactivity Disorder · Sleep Disturbance
Bottom Line
View on ClinicalTrials.gov: NCT03730194 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Actigraphy (Total Sleep Time) — 7.08; 7.03; 7.16; 7.01 Time (hours.minutes of nightly sleep)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Melatonin (Dietary_supplement); Bedtime Bank (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actigraphy (Total Sleep Time) |
7.08; 7.03; 7.16; 7.01; 7.06; 7.29 | — |
| PRIMARY AARP- Abbreviated Acceptability Rating Profile |
38.84; 34.00; 38.84; 37.89 | — |
| SECONDARY Urinary Melatonin |
81.90; 78.58 | — |
| SECONDARY PROMIS Pediatric Item Bank Sleep Related Impairment |
58.73; 58.37; 53.87; 53.56; 52.76; 51.62 | — |
| SECONDARY PROMIS Pediatric Item Bank Sleep Disturbance |
63.37; 64.160; 59.46; 59.20; 56.57; 56.65 | — |
| SECONDARY Cleveland Adolescent Sleepiness Questionnaire (CASQ) |
37.70; 41.50; 35.21; 38.79; 33.74; 38.42 | — |
Summary
The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).
Eligibility Criteria
Inclusion Criteria
- Age 10-18 years and consistently living with parental (or legal guardian) supervision.
- Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
- Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ>70).
- Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
- Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.
Exclusion Criteria
- Unwillingness to stop melatonin 2 months prior to enrollment in the study.
- Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
- Adolescents who are not able to take oral medication.
- Adolescents who are visually impaired with known inability to detect light.
- Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
- Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.
Data sourced from ClinicalTrials.gov (NCT03730194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.