CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Melatonin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03730194
NCT03730194N/ACompleted
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A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

University of Nebraska·interventional·Posted Nov 5, 2018·Updated Dec 22, 2023

In Brief

A clinical study evaluating Melatonin and Bedtime Bank for Autism Spectrum Disorder and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartMay 31, 2019
Primary CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.7 years ago

Interventions

Melatonindietary

Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime

Bedtime Bankbehavioral

The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.