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NCT05716906 · ClinicalTrials.gov registry record · NA

Melatonin and Sleep Spindles in Autism

A NA study of Autism Spectrum Disorder, sponsored by Massachusetts General Hospital.

Active
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT05716906 is a NA study of Autism Spectrum Disorder that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05716906, a NA study of Autism Spectrum Disorder, is active but no longer recruiting, sponsored by Massachusetts General Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Melatonin

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-01-11
Est. Completion 2025-12-31
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT05716906

The ClinicalTrials.gov registry entry for NCT05716906 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (78% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Melatonin is the first listed.

NCT05716906 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05716906 about?

NCT05716906 is a clinical study titled "Melatonin and Sleep Spindles in Autism". Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This ...

What is the current status of trial NCT05716906?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-01-11. Estimated completion is 2025-12-31.

What conditions does trial NCT05716906 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

What interventions are being tested in trial NCT05716906?

The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05716906?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05716906 being conducted?

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

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