Sleep Disturbances in Hospitalized Children

NCT00749814 | Unknown Phase 4

• 1 other identifier: TASMC-08-YS-371-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disorders

Keywords

sleep patterns in children in the night prior to surgery and post surgery.; the influence of melatonin on sleep patterns

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency

  1. Night before surgery, 2. Nights in hospital after surgery

Study Arms (3)

A

EXPERIMENTAL

Study group will receive melatonin.

Dietary Supplement: Melatonin

B

PLACEBO COMPARATOR

Placebo

Other: Placebo tablets

C

NO INTERVENTION

No intervention control group.

Interventions

Melatonin DIETARY_SUPPLEMENT

Melatonin slow release tablets, 2 mg, 1 hour before bedtime for 7 days prior to admission to the hospital and up to 7 days after surgery.

Also known as: Circadin (melatonin 2 mg)

A

Placebo tablets OTHER

Placebo

B

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 4-18 years scheduled for elective surgery in the general pediatric surgery, pediatric orthopedics, pediatric urology and the pediatric plastic departments

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yakov Sivan, MD

CONTACT

97236974614; sivan@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Last Updated: September 9, 2008

Record last verified: 2008-08

Locations

IL (1)