Melatonin and Sleep Spindles in Autism

Autism Spectrum Disorder Clinical Trial

Official title:

The Effects of Melatonin on Sleep Spindles in Children With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716906
• Other study ID #: 2021P002832
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Dara Manoach, PhD
• Phone: 617-724-6148
• Email: manoachlab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Dietary Supplement:
• Melatonin
5mg gummy 30 min before bedtime for 2 consecutive nights

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five nights of sleep over two weeks
Secondary	Change in sleep quality	Change in sleep quality between baseline and melatonin nights	Five nights of sleep over two weeks