Sleep DisordersPhase 4NCT00749814
Sleep Disturbances in Hospitalized Children
A Phase 4 study testing Melatonin in people with Sleep Disorders, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 4-18 years scheduled for elective surgery in the general pediatric surgery, pediatric orthopedics, pediatric urology and the pediatric plastic departments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Data for each participant will be collected from the medical records and will include: demographic data, gender, and clinical background. Underlying sleep disorders will be screened by an accepted and validated sleep questionnaire [28] (appendix A) The study will consist of 5 sequential and continual steps: step 1 - the week prior to admission to the hospital; step 2 - the night before surgery; step 3 - anesthesia and surgery; step 4 - the post operative hospital stay; step 5 - home, 2 weeks after discharge.
Step 1: all 90 patients will undergo sleep evaluation by actigraphy and a sleep log (appendix B), for 7 days prior to surgery in their usual sleep environment at home.
Step 2: the patients will be divided into 3 study groups in a double-blind, placebo-controlled randomization:
- Thirty children will receive melatonin (Circadin) 2 mg, one hour before bedtime and will consist of study group A.
- Thirty age, gender and disease matched controls will receive placebo and will consist of placebo group A.
- Thirty age, gender and disease matched children will not receive anything (control group).
Actigraphy and completion of sleep questionnaire will be also performed in hospital in the night prior to surgery.
Step 3: stress assessment during anesthesia and surgery will be assessed by the following variables that are routinely monitored and recorded during surgery by the MDsoft computerized system: heart rate, blood pressure, end-tidal CO2, amount of anesthetic agents, opiate consumption.
Step 4: actigraphy and completion of sleep questionnaire will be performed in each night of the post-surgery hospital stay period and up to 1 week post-surgery.
Step 5: two weeks after discharge, an additional follow-up sleep log and actigraphy will be performed for 5 consecutive nights.
Practically, children will be recruited in triplicates so that each triple will consist of the same gender, age and type of surgery. By randomization they will be assigned to one of each of the study groups.
Post operatively, each pair of patients of study group A and the placebo group A (not including control group) will be randomly re-divided into two new groups: study group B - children who will receive melatonin every night and control group B who will receive placebo every night one hour before bedtime for the rest of the hospitalization.
Sleep evaluation:
Sleep will be evaluated by sleep log which is a diary of sleep variables completed by parents after each night (appendix B) and by actigraphy.
Actigraphy An actigraph is a watch-like device that is placed on the wrist. It is a noninvasive continuous ambulatory measure used to objectively evaluate sleep. The use of actigraphy for both clinical and research purposes is well established. Actigraphy is a reliable and valid tool for detecting disturbed sleep and a useful technique for the evaluation of insomnia and circadian rhythm disorders [10]. It is an accepted and common technique in children [29] and is routinely used in our pediatric sleep clinic.
- Conditions
- Sleep Disorders
- Being tested
- Melatonin, Placebo tablets
- Keywords
- sleep patterns in children in the night prior to surgery and post surgery., the influence of melatonin on sleep patterns
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Also called Circadin (melatonin 2 mg)
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.
Placebo tabletsOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Study group will receive melatonin. Receives: Dietary Supplement: Melatonin |
| B | Placebo comparator | Placebo Receives: Other: Placebo tablets |
| C | No intervention | No intervention control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Measured: 1. Night before surgery, 2. Nights in hospital after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749814
- Sponsor's protocol ID
- TASMC-08-YS-371-CTIL
- Status last verified
- Aug 2008
- First submitted
- 8 Sep 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances in Hospitalized Children
- ClinicalTrials.gov ID
- NCT00749814
- Acronym / sponsor ID
- TASMC-08-YS-371-CTIL
- Conditions
- Sleep Disorders
- Keywords
- sleep patterns in children in the night prior to surgery and post surgery., the influence of melatonin on sleep patterns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data for each participant will be collected from the medical records and will include: demographic data, gender, and clinical background. Underlying sleep disorders will be screened by an accepted and validated sleep questionnaire [28] (appendix A) The study will consist of 5 sequential and continual steps: step 1 - the week prior to admission to the hospital; step 2 - the night before surgery; step 3 - anesthesia and surgery; step 4 - the post operative hospital stay; step 5 - home, 2 weeks after discharge.
Step 1: all 90 patients will undergo sleep evaluation by actigraphy and a sleep log (appendix B), for 7 days prior to surgery in their usual sleep environment at home.
Step 2: the patients will be divided into 3 study groups in a double-blind, placebo-controlled randomization:
- Thirty children will receive melatonin (Circadin) 2 mg, one hour before bedtime and will consist of study group A.
- Thirty age, gender and disease matched controls will receive placebo and will consist of placebo group A.
- Thirty age, gender and disease matched children will not receive anything (control group).
Actigraphy and completion of sleep questionnaire will be also performed in hospital in the night prior to surgery.
Step 3: stress assessment during anesthesia and surgery will be assessed by the following variables that are routinely monitored and recorded during surgery by the MDsoft computerized system: heart rate, blood pressure, end-tidal CO2, amount of anesthetic agents, opiate consumption.
Step 4: actigraphy and completion of sleep questionnaire will be performed in each night of the post-surgery hospital stay period and up to 1 week post-surgery.
Step 5: two weeks after discharge, an additional follow-up sleep log and actigraphy will be performed for 5 consecutive nights.
Practically, children will be recruited in triplicates so that each triple will consist of the same gender, age and type of surgery. By randomization they will be assigned to one of each of the study groups.
Post operatively, each pair of patients of study group A and the placebo group A (not including control group) will be randomly re-divided into two new groups: study group B - children who will receive melatonin every night and control group B who will receive placebo every night one hour before bedtime for the rest of the hospitalization.
Sleep evaluation:
Sleep will be evaluated by sleep log which is a diary of sleep variables completed by parents after each night (appendix B) and by actigraphy.
Actigraphy An actigraph is a watch-like device that is placed on the wrist. It is a noninvasive continuous ambulatory measure used to objectively evaluate sleep. The use of actigraphy for both clinical and research purposes is well established. Actigraphy is a reliable and valid tool for detecting disturbed sleep and a useful technique for the evaluation of insomnia and circadian rhythm disorders [10]. It is an accepted and common technique in children [29] and is routinely used in our pediatric sleep clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: MelatoninStudy group will receive melatonin. |
| B | Placebo comparator | Other: Placebo tabletsPlacebo |
| C | No intervention | –No intervention control group. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age: 4-18 years scheduled for elective surgery in the general pediatric surgery, pediatric orthopedics, pediatric urology and the pediatric plastic departments
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Circadin (melatonin 2 mg)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. | Dietary supplement | A |
| Placebo tabletsPlacebo | Other | B |
Primary outcome
Sleep efficiency
Time frame: 1. Night before surgery, 2. Nights in hospital after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Sleep Disorders, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yakov Sivan, MD (97236974614, sivan@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: 1. Night before surgery, 2. Nights in hospital after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2008.