Sleep Disorders Clinical Trial
Background
Sleep disturbances are prevalent in hospitalized adult patients manifested as reduced sleep
time and sleep efficiency as well as increased awakenings. Insomnia is the most frequent
sleep disturbance. The effect of the change in sleep patterns in children prior to and after
an elective surgery has not been evaluated objectively. Sleep in hospital may influence
biological processes related to circadian rhythm.
Melatonin is a hormone secreted by the pineal gland in a diurnal rhythm regulated by light-
light suppresses melatonin secretion, while darkness enhances it. Melatonin has both
chrono-biotic and sleep promoting properties. Exogenous administration of melatonin shortens
sleep latency, increases sleep efficiency and total sleep time. Melatonin also improves
disrupted circadian rhythm. Melatonin promotes sleep in a similar way to the natural sleep
process, and maintains normal sleep architecture.
Melatonin has a positive effect on children with sleep disturbances and is routinely
administrated in pediatric sleep centers around the world for insomnia and a variety of
sleep disorders. Side effects of melatonin are rare and scarce. Circadin is a slow released
formulation of melatonin, which mimics night time secretion of natural melatonin. Children
with sleep disorders who were treated with controlled release melatonin, demonstrated
improvement in sleep latency and total sleep time.
It is reasonable to assume that hospitalized children have disturbed sleep patterns prior to
and following elective surgery. We hypothesize that melatonin will improve sleep patterns
prior to and following surgery, by reducing sleep latency and extending total sleep time. We
also hypothesize that this improvement will have positive impact on anesthetic stress
measures and on recovery.
The purposes of the study are: 1. To characterize sleep patterns in children undergoing
surgery on the admission night prior to surgery; 2. To evaluate the effect of melatonin on
sleep parameters on the night prior to surgery in children; 3. To evaluate the effect of
melatonin on physiologic stress parameters during anesthesia and surgery in children; 4. To
evaluate the effect of melatonin on sleep parameters of children postoperatively; 5. To
evaluate the effect of melatonin on postoperative outcome measures in children.
Patients, Methods. Ninety children (aged 4-18 years) will be evaluated. Sleep disorders will
be screened by a pediatric sleep questionnaire. Sleep will be assessed by sleep logs and
actigraphy for sleep onset time, sleep latency, total sleep time, total wake time, number
and length of awakenings, sleep efficiency, sleep fragmentation index and sleep mean
activity score. Recovery measures will include: length of hospitalization, infection rate,
body temperature, cortisol levels, cooperation with medical staff.
Study plan. The research will comprise of 5 consecutive steps. Step 1 will include the week
prior to surgery and include sleep evaluation to all participants by sleep log and
actigraphy. Step 2 is the night prior to surgery and will include sleep log and actigraphy.
30 children will receive melatonin (Circadin) 2mg, 30 children will receive placebo and 30
children will constitute the control group. Step 3 will be conducted during anesthesia and
surgery where stress variables and need for anesthesia will be recorded. Step 4 will take
place during post-operative hospitalization and will include actigraphy and sleep logs. Step
5 will take place at home two weeks after discharge and will include actigraphy and sleep
logs.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Age: 4-18 years scheduled for elective surgery in the general pediatric surgery, pediatric orthopedics, pediatric urology and the pediatric plastic departments Exclusion Criteria: - An underlying known sleep disorder such as delayed sleep phase syndrome, sleep-disordered breathing and insomnia - An underlying medical condition that may directly affect sleep (state of decreased consciousness, brain surgery) - Taking medications that may affect sleep - Impairment of renal or liver functions - Autoimmune diseases - Known galactose intolerance, lactase deficiency, glucose-galactose malabsorption |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency | 1. Night before surgery, 2. Nights in hospital after surgery | No |
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