Investigating melatonin's effects on sleep spindles in autism
The Effects of Melatonin on Sleep Spindles in Children With Autism
NA · Massachusetts General Hospital · NCT05716906
This study is testing if melatonin can improve sleep quality and brain activity during sleep in children with autism who have trouble sleeping and sensory sensitivities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05716906 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between sleep spindles, sleep quality, and sensory sensitivities in children with Autism Spectrum Disorder (ASD). It hypothesizes that disrupted communication between the thalamus and cortex contributes to these issues, which can be assessed through sleep spindles. The study will examine whether melatonin, a common sleep aid, can enhance sleep spindles in this population. By understanding these connections, the research aims to identify the thalamic reticular nucleus as a potential treatment target for sleep disruptions in autism.
Who should consider this trial
Good fit: Ideal candidates are English-speaking males and females aged 12-18 diagnosed with Autism Spectrum Disorder.
Not a fit: Patients with chronic medical conditions affecting sleep, diagnosed sleep disorders, or known genetic causes of ASD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced sensory sensitivities in children with autism.
How similar studies have performed: While the specific approach of targeting sleep spindles in autism is novel, melatonin has been previously studied for sleep issues in various populations with some success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Dara Manoach, PhD — Professor
- Study coordinator: Dara Manoach, PhD
- Email: manoachlab@gmail.com
- Phone: 617-724-6148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Melatonin