Circadian Rhythm Sleep DisorderCLOCKSkidsNCT05618405
Changes in Circadian Rhythm After Anaesthesia in Children
An observational study of Circadian Rhythm Sleep Disorder and Circadian Rhythm Disorder Caused by Drug, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Circadian Rhythm Sleep Disorder, Circadian Rhythm Disorder Caused by Drug, Circadian Rhythm Sleep Disorder, Jet Lag Type
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Mar 2022to 1 Jun 2024
- Phase
- Observational
- 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 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia
Who may be able to join
- General anaesthesia for surgery or magnetic resonance imaging (MRI) with a minimal duration of 30 minutes
- Age 1-11 years
- Informed consent of both parents
Who cannot join
- Parents are not fluent in Dutch
- Known severe sleep disturbances
- Postoperative admission to paediatric intensive care unit
- Moderate to severe developmental disorder (IQ<85)
- American Society of Anesthesiologists (ASA) classification > 3
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105AZ
About this study
Official title: The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study
In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.
Read the detailed description
Objective:
The primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery.
Secondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication.
Study procedures:
Possible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference.
Questionnaires:
- Sleep quality: Child's Sleep Habits Questionnaire (CSHQ) on day 3 preoperative and on day 7 postoperative.
- Chronotype: Children's chronotype questionnaire on day 3 preoperative
- Daily sleep diary starting from 3 days preoperative until 7 days postoperative
The following items will be extracted from the electronic health record:
- Demographic criteria: age, gender, type of procedure
- Admission dates
- Preoperative sedative medication
- Postoperative sedative medication
- NRS/FLACC scores during hospital stay All items will be entered in an electronic database (CASTOR)
Primary endpoint The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.
Secondary endpoints
- Change in sleep quality as measured with the CSHQ questionnaire
- Incidence of postoperative sleep problems as measured with the CSHQ questionnaire
- Difference in sleep problems, sleep duration and sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
- Influence of pain and sedative medication on sleep duration and quality
- Conditions
- Circadian Rhythm Sleep Disorder, Circadian Rhythm Disorder Caused by Drug, Circadian Rhythm Sleep Disorder, Jet Lag Type, Jet Lag, Anesthesia, Sleep
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Jet Lag Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children who undergo anesthesia because of surgery | Children, aged between 1-11 years, who undergo general anesthesia because of surgery. | |
| Children who undergo anesthesia because of an MRI | Children, aged between 1-11 years, who undergo general anesthesia because of an MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diurnal phase shift
The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.
Measured: Baseline (1wk before anesthesia) - First night post-anesthesia
Secondary outcomes (4)
Change in sleep quality
The change in subjective sleep quality, including incidence of sleep problems (e.g. sleepwalking, nightmares), as measured by the Children's Sleep Habits Questionnaire (CSHQ), between the month prior to 3 nights pre-anesthesia and 1 week post-anesthesia. This is measured on a likert scale 1 meaning no sleep problems and 5 meaning a lot of sleep problems. The answers from questionnaire 1 (3 days preoperative) are compared to answers of questionnaire 2 (7 days postoperative)
Measured: 3 days pre-anaesthesia - 7 days post-anaesthesia
Changes in all sleep times
Changes in all sleep parameters (i.e. sleep on- and offset times, sleep duration, sleep latency) when comparing baseline (as measured by the Children's ChronoType Questionnaire (CCTQ) 3 days pre-anesthesia) to all 10 nights of the sleeping log.
Measured: 3 days pre-anaesthesia - 7 days post-anaesthesia
Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
Difference in subjective sleep quality (as measured by the CSHQ) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure. Answers are on a likerts scale with 1 meaning no sleep problems and 5 meaning a lot of sleep problems.
Measured: 3 days pre-anaesthesia - 7 days post-anaesthesia
Difference in sleep-wake timing
Difference in changes in sleep-wake timing (as measured by the sleeping log, units are minutes) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure
Measured: 3 days pre-anaesthesia - 7 days post-anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start16 Mar 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorinde Polderman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jeroen Hermanides, Prof, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618405
- Sponsor's protocol ID
- W22_068
- Acronym
- CLOCKSkids
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study
- ClinicalTrials.gov ID
- NCT05618405
- Acronym / sponsor ID
- CLOCKSkids / W22_068
- Conditions
- Circadian Rhythm Sleep Disorder, Circadian Rhythm Disorder Caused by Drug, Circadian Rhythm Sleep Disorder, Jet Lag Type, Jet Lag, Anesthesia, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- 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.
In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.
Detailed description
Objective:
The primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery.
Secondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication.
Study procedures:
Possible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference.
Questionnaires:
- Sleep quality: Child's Sleep Habits Questionnaire (CSHQ) on day 3 preoperative and on day 7 postoperative.
- Chronotype: Children's chronotype questionnaire on day 3 preoperative
- Daily sleep diary starting from 3 days preoperative until 7 days postoperative
The following items will be extracted from the electronic health record:
- Demographic criteria: age, gender, type of procedure
- Admission dates
- Preoperative sedative medication
- Postoperative sedative medication
- NRS/FLACC scores during hospital stay All items will be entered in an electronic database (CASTOR)
Primary endpoint The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.
Secondary endpoints
- Change in sleep quality as measured with the CSHQ questionnaire
- Incidence of postoperative sleep problems as measured with the CSHQ questionnaire
- Difference in sleep problems, sleep duration and sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
- Influence of pain and sedative medication on sleep duration and quality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children who undergo anesthesia because of surgery | – | –Children, aged between 1-11 years, who undergo general anesthesia because of surgery. |
| Children who undergo anesthesia because of an MRI | – | –Children, aged between 1-11 years, who undergo general anesthesia because of an MRI. |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia
Key inclusion criteria (3 listed)
- General anaesthesia for surgery or magnetic resonance imaging (MRI) with a minimal duration of 30 minutes
- Age 1-11 years
- Informed consent of both parents
Key exclusion criteria (5 listed)
- Parents are not fluent in Dutch
- Known severe sleep disturbances
- Postoperative admission to paediatric intensive care unit
- Moderate to severe developmental disorder (IQ<85)
- American Society of Anesthesiologists (ASA) classification > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diurnal phase shift
Time frame: Baseline (1wk before anesthesia) - First night post-anesthesia
The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.
4 secondary outcomes
Change in sleep quality
Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia
Changes in all sleep times
Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia
Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia
Difference in sleep-wake timing
Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
Jeroen Hermanides, Prof principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm Sleep Disorder and Circadian Rhythm Disorder Caused by Drug, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2024. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diurnal phase shift (time frame: Baseline (1wk before anesthesia) - First night post-anesthesia). 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 31 Jul 2024.