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Oral Melatonin Supplementation for Sleep Disturbances in Children with Cerebral Palsy: A Randomized Double-Blind
Gire Pooja K1, Smita Mundada2, Janhavi Zambani3
1Consultant Pediatric Intensivist, Manipal Hospitals Pvt Ltd, Pune, Maharashtra, India.
Insights
Oral melatonin effectively improves sleep in children with cerebral palsy (CP). This treatment significantly reduces sleep onset latency and increases total sleep time with minimal side effects.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Pharmacology
Background:
- Sleep problems are common in children with cerebral palsy (CP).
- Non-pharmacological therapies are often insufficient for CP-related sleep disturbances.
Purpose of the Study:
- To evaluate the efficacy and safety of oral melatonin for treating sleep issues in children with CP.
- To determine melatonin's impact on sleep onset latency and total sleep time.
Main Methods:
- A 12-week, randomized, double-blind, placebo-controlled trial involving 120 children (3-12 years) with CP and sleep problems.
- Participants received oral melatonin (3-10 mg) or placebo daily.
- Sleep measures included the Sleep Disturbance Scale for Children (SDSC) and caregiver-reported sleep diaries.
Main Results:
- Melatonin significantly reduced sleep onset latency at 4 and 12 weeks (P < 0.001).
- Total sleep time significantly increased with melatonin treatment at 4 and 12 weeks (P < 0.001).
- Melatonin was well-tolerated, with minimal adverse effects reported.
Conclusions:
- Oral melatonin (3-10 mg daily) is an effective treatment for reducing sleep onset latency in children with CP.
- Melatonin significantly improves total sleep time in this population.
- The treatment demonstrates a favorable safety profile with minimal side effects.
Objectives:
To assess the efficacy and safety of oral melatonin in treating sleep problems in children with cerebral palsy (CP).
Methods:
A randomized, double-blind, placebo-controlled trial was conducted at a tertiary care government hospital in 120 children with CP (3 to 12 y) suffering from sleep problems and who failed to respond to non-pharmacological therapy (4 wk). Participants were randomized to receive oral melatonin (3 mg escalated to 10 mg)/ placebo for 12 wk. Sleep measures included the Sleep Disturbance Scale for Children (SDSC), and caregivers reported sleep and nap diaries (SND). Outcome measures included decreased sleep onset latency (SOL) and increased total sleep time (TST) calculated using sleep diaries at 4 and 12 wk.
Results:
The mean (SD) total sleep time in the melatonin and placebo groups was 5.09 (0.76) vs. 4.90 (0.77) h [Mean difference (MD) 0.19; P = 0.17] at baseline; 5.66 (0.84) vs. 4.89 (0.83) h (MD 0.77; P < 0.001) at 4 wk; 6.29 (0.78) vs. 4.98 (0.85) h (MD 1.31; P < 0.001) at 12 wk, respectively. The mean (SD) sleep onset time in melatonin and placebo groups was 79.18 ± 17.89 vs. 76.78 ± 13.60 min (MD 2.4; P = 0.41) at baseline; 63.70 ± 16.63 vs. 72.89 ± 15.38 min (MD 9.19; P < 0.003) at 4 wk; 43.20 ± 15.57 vs. 70.92 ± 14.95 min (MD 27.72; P < 0.001) at 12 wk, respectively. Melatonin was well tolerated with minimal side effects (n = 10).
Conclusions:
Melatonin, at a dose range of 3-10 mg once daily can significantly reduce SOL and improve TST in children with CP who have sleep problems with minimal adverse effects.
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