33946
document
A randomized , placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities . The purpose of this study was to determine the efficacy of controlled-release ( CR ) melatonin in the treatment of delayed sleep phase syndrome and impaired sleep maintenance of children with neurodevelopmental disabilities including autistic spectrum disorders . A randomized double-blind , placebo-controlled crossover trial of CR melatonin ( 5 mg ) followed by a 3-month open-label study was conducted during which the dose was gradually increased until the therapy showed optimal beneficial effects . Sleep characteristics were measured by caregiver who completed somnologs and wrist actigraphs . Clinician rating of severity of the sleep disorder and improvement from baseline , along with caregiver ratings of global functioning and family stress were also obtained . Fifty-one children ( age range 2-18 years ) who did not respond to sleep hygiene intervention were enrolled . Fifty patients completed the crossover trial and 47 completed the open-label phase . Recordings of total night-time sleep and sleep latency showed significant improvement of approximately 30 min . Similarly , significant improvement was observed in clinician and parent ratings . There was additional improvement in the open-label somnolog measures of sleep efficiency and the longest sleep episode in the open-label phase . Overall , the therapy improved the sleep of 47 children and was effective in reducing family stress . Children with neurodevelopmental disabilities , who had treatment resistant chronic delayed sleep phase syndrome and impaired sleep maintenance , showed improvement in melatonin therapy .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
melatonin treatment
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Intervention_Pharmacological
melatonin
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
CR melatonin
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Intervention_Pharmacological
melatonin therapy .
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Outcome_Other
efficacy
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Outcome_Physical
Sleep characteristics
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Outcome_Other
Clinician rating
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Outcome_Other
caregiver ratings
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Outcome_Physical
total night-time sleep
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Outcome_Physical
sleep latency
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Outcome_Other
clinician and parent ratings .
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Outcome_Physical
open-label somnolog measures
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Outcome_Physical
sleep efficiency
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Outcome_Physical
the longest sleep episode
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Outcome_Physical
improved the sleep
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Outcome_Mental
effective in reducing family stress
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Outcome_Physical
treatment resistant chronic delayed sleep phase syndrome
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Outcome_Physical
impaired sleep maintenance
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Participant_Condition
delayed sleep phase syndrome
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Participant_Condition
impaired sleep maintenance
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Participant_Age
children
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Participant_Condition
neurodevelopmental disabilities
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Participant_Condition
delayed sleep phase syndrome
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Participant_Condition
impaired sleep maintenance
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Participant_Age
children
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Participant_Condition
neurodevelopmental disabilities
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Participant_Condition
autistic spectrum disorders
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Participant_Sample-size
Fifty-one
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Participant_Age
children ( age range 2-18 years )
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Participant_Age
Children
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Participant_Condition
neurodevelopmental disabilities
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Participant_Condition
treatment resistant chronic delayed sleep phase syndrome