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Leptin as a biomarker of sleep dysregulation in children with ASD: A drug-free cohort study

M. Carotenuto, M. Gnazzo, G. Bargiacchi, Valentina Baldini, G. Umano, G. Messina, M. Monda, D. Smirni et al.

Sleep Medicine, 2026

2 citations

Abstract

OBJECTIVE

Autism spectrum disorder (ASD), typically diagnosed before the age of three, is characterized by deficits in social interaction, communication, and repetitive behaviors. Sleep disturbances are highly prevalent in ASD and have been associated with altered neuroendocrine regulation. Leptin, a hormone involved in metabolic balance and circadian rhythms, has been proposed as a potential biomarker of sleep and neurodevelopmental dysfunction. This study aimed to explore the association between serum leptin levels, sleep habits, and autism symptomatology in a cohort of children with ASD.

MATERIALS AND METHODS

A total of 76 medication-naïve children with ASD (mean age: 6.86 ± 1.88; range 4-11 years), defined as no current or previous exposure to psychotropic or sleep-modifying medications (including melatonin, stimulants, antihistamines, antidepressants, and antipsychotics), were compared to 105 age-matched typically developing controls. ASD diagnosis was based on DSM-5 criteria and confirmed using ADOS-2, ADI-R, and SRS-2. Sleep disturbances were assessed using the caregiver-reported Sleep Disturbance Scale for Children (SDSC) and fasting morning blood samples were collected to measure serum leptin levels.

RESULTS

Children with ASD showed significantly higher SDSC total scores (p < 0.001) and leptin levels (p < 0.001) compared to controls. Significant positive correlations were observed between leptin levels and sleep disturbance scores as well as autism severity measures…

How strong is the evidence?

Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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