ACTIVE_NOT_RECRUITING

Melatonin and Sleep Spindles in Autism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Melatonin on Sleep Spindles in Children With Autism

Quick Facts

Study Start:2023-01-11
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05716906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female subjects with ASD
  2. * 12-18 years of age
  3. * English speaking
  4. * Able to understand and respond to questionnaires in English
  1. * Pregnant or breastfeeding
  2. * Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
  3. * Chronic medical conditions that affect sleep
  4. * Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
  5. * History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
  6. * IQ \<70
  7. * Other neurological disorder, including seizure disorder
  8. * Diagnosed sleep disorder
  9. * Known genetic causes of ASD
  10. * Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Contacts and Locations

Principal Investigator

Dara Manoach, PhD
PRINCIPAL_INVESTIGATOR
Professor

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Dara Manoach, PhD, PRINCIPAL_INVESTIGATOR, Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-01-11
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Melatonin

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder