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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: Active NA study of Autism Spectrum Disorder, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Melatonin
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT05716906 still lists
NCT05716906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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 NCT05716906's enrollment target sits among peer trials
30 170th of 224 higher than 50 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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