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document
Milk intolerance in children with persistent sleeplessness : a prospective double-blind crossover evaluation . From July 1986 to July 1988 , 146 children less than 5 years of age were referred by their physicians to our university sleep clinic for continual waking and crying during sleep hours . For 85 children ( 58.2 % ) , the sleeplessness was attributed to inappropriate sleep habits . For 17 children ( 11.6 % ) , no explanation was found for the sleep difficulties in spite of an extensive workup . Their median age at referral was 13.5 months ( range 2.5 to 29 months ) . Their persistent sleeplessness was tentatively attributed to an undiagnosed intolerance to cow 's milk . Cow 's milk was excluded from their diet . In 15 children sleep normalized after 5 weeks ( range 4 to 6 weeks ) . As seen from the parents ' logs , the median time needed by the children to fall asleep decreased from 15 minutes ( range 15 to 60 minutes ) to 10 minutes ( range 10 to 15 minutes , P = .001 ) . The number of complete arousals decreased from 5 ( range 1 to 12 ) to less than 1 per night ( range 0 to 2 ) ( P = .001 ) . Total sleep time per 24 hours increased from 5.5 hours ( range 3 to 8.5 hours ) to 13.0 hours ( range 10 to 14.5 hours , P = .001 ) . Sleep normalized in one child who continued to receive no cow 's milk only after the hydrolyzed hypoallergenic diet was discontinued . In every child , a double-blind crossover challenge was conducted involving a control diet containing no cow 's milk and a diet containing cow 's milk . The challenge induced the reappearance of insomnia and agitated behavior in all except one child . The child 's initial sleep difficulties were retrospectively attributed to inappropriate sleep habits . ( ABSTRACT TRUNCATED AT 250 WORDS )
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Intervention_Pharmacological
Cow 's milk was excluded from their diet
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Intervention_Control
control diet containing no cow 's milk
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Intervention_Pharmacological
diet containing cow 's milk
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Outcome_Physical
Milk intolerance
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Outcome_Mental
median time needed by the children to fall asleep
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Outcome_Mental
number of complete arousals
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Outcome_Mental
Total sleep time per 24 hours
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Outcome_Mental
Sleep
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Outcome_Mental
reappearance of insomnia and agitated behavior