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NCT03730194 · ClinicalTrials.gov registry record · NA

A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

A NA study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, sponsored by University of Nebraska.

Completed
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT03730194: Completed NA study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, sponsored by University of Nebraska.

NCT03730194 is a NA study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder that has completed, run by University of Nebraska. The registered enrollment target is 40 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03730194, a NA study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity. A sleep diary was utilized to guide data analysis.

Interventions

  • DIETARY_SUPPLEMENT Melatonin
  • BEHAVIORAL Bedtime Bank

Study Locations (1)

Nebraska

  • University of Nebraska Medical Center, Center for Nursing Science - Omaha

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-05-31
Est. Completion 2021-11-01
Phase NA
University of Nebraska

407 total trials

What the finished NCT03730194 record still lists

NCT03730194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (70% lower).

The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Melatonin is the first listed.

NCT03730194 reports a single indexed study location in Nebraska.

Frequently Asked Questions

What is clinical trial NCT03730194 about?

NCT03730194 is a clinical study titled "A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders". 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 diso...

What is the current status of trial NCT03730194?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-05-31. Estimated completion is 2021-11-01.

What conditions does trial NCT03730194 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance.

What interventions are being tested in trial NCT03730194?

The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Bedtime Bank (BEHAVIORAL).

Who is sponsoring clinical trial NCT03730194?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03730194 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Autism Spectrum Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03730194's enrollment target sits among peer trials

40 156th of 224 higher than 61 of 224 other Autism Spectrum Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03730194, the US trial registry maintained by the National Library of Medicine. NCT03730194 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.