search
Back to results

Melatonin and Sleep Spindles in Autism

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring Melatonin

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female subjects with ASD 12-18 years of age English speaking Able to understand and respond to questionnaires in English Exclusion Criteria: Pregnant or breastfeeding Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary) Chronic medical conditions that affect sleep Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease History of head injury resulting in prolonged loss of consciousness or other neurological sequelae IQ <70 Other neurological disorder, including seizure disorder Diagnosed sleep disorder Known genetic causes of ASD Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melatonin

Arm Description

5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Outcomes

Primary Outcome Measures

Change in sleep spindle density
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.

Secondary Outcome Measures

Change in sleep quality
Change in sleep quality between baseline and melatonin nights

Full Information

First Posted
January 30, 2023
Last Updated
February 7, 2023
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05716906
Brief Title
Melatonin and Sleep Spindles in Autism
Official Title
The Effects of Melatonin on Sleep Spindles in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Melatonin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
5mg melatonin gummy 30 min before bedtime for 2 consecutive nights
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
5mg gummy 30 min before bedtime for 2 consecutive nights
Primary Outcome Measure Information:
Title
Change in sleep spindle density
Description
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.
Time Frame
Five nights of sleep over two weeks
Secondary Outcome Measure Information:
Title
Change in sleep quality
Description
Change in sleep quality between baseline and melatonin nights
Time Frame
Five nights of sleep over two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects with ASD 12-18 years of age English speaking Able to understand and respond to questionnaires in English Exclusion Criteria: Pregnant or breastfeeding Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary) Chronic medical conditions that affect sleep Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease History of head injury resulting in prolonged loss of consciousness or other neurological sequelae IQ <70 Other neurological disorder, including seizure disorder Diagnosed sleep disorder Known genetic causes of ASD Currently taking melatonin or those who have had an adverse reaction to melatonin in the past
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dara Manoach, PhD
Phone
617-724-6148
Email
manoachlab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Townsend, PhD
Phone
617-702-2368
Email
ptownsend2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dimitrios Mylonas, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, after publication of the results. Workflows will be documented and will allow any external groups to reproduce results from the raw data.
IPD Sharing Time Frame
Data will be available following the publication of the results.

Learn more about this trial

Melatonin and Sleep Spindles in Autism

We'll reach out to this number within 24 hrs