Clinical Research Directory

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Cerebral palsy (CP) is a lifelong condition affecting movement and posture, often requiring substantial care from family members. Children with CP frequently experience sleep disturbances associated with motor impairment, pain, seizures, and other clinical factors. Sleep difficulties may also be associated with poor sleep quality, psychological symptoms, and increased burden among caregivers. This single-center, observational, cross-sectional study evaluated sleep characteristics in children with CP, caregiver sleep quality, and caregiver burden, as well as their associations with functional status and caregiver psychological symptoms. The study included 61 children with CP and their primary caregivers. Eligible children were aged 2-18 years. Children's sleep characteristics were assessed using a 33-item parent-reported questionnaire adapted from the Children's Sleep Habits Questionnaire (CSHQ), which was not identical to the validated Turkish CSHQ. Children's functional characteristics were evaluated using GMFCS, MACS, and CFCS. Caregiver sleep quality, caregiver burden, and psychological symptoms were assessed using the Pittsburgh Sleep Quality Index (PSQI), Zarit Burden Interview (ZBI), and Hospital Anxiety and Depression Scale (HADS), respectively. The study was designed to examine associations among child sleep characteristics, caregiver sleep quality, caregiver burden, and psychological well-being.

Melatonin Adolescent Research Study

The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).

Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)

Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population. Pediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN. MELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep. Participants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored. The study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.

Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.