Cranial Nerve DiseasesNCT03659760
: Association of Melatonin Levels and Light and Noise Isolation in ICU
A study testing Group Isolated in people with Cranial Nerve Diseases, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory. In this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cranial Nerve Diseases
- What is being tested?
- Group Isolated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2018to 25 Apr 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Glasgow Coma Scale(GCS) >14
Who cannot join
- Glasgow Coma Scale(GCS) <14
- Patients who do not understand the questions, not awake
- Patient who treated with hormones
- Patient with infection or inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara
About this study
Official title: Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit
Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory.
In this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery
Read the detailed description
Patients with Glasgow coma scale (GKS) >14, American Society of Anesthesiologist (ASA) I-III, intensive care patients underwent transcranial surgery will be included
Patients will be randomly allocated by a computer generated random numbers list into two groups.
Patients with sleep disruptions (Group I) (exposed to ambient light and noise) and Patients without sleep disruptions (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Melatonin levels will be measured by urine 6-sulfatoxymelatonin (a-MT6) levels, which is a product of melatonin degradation at 07:00 am preoperative and postoperative day 1 and day 3.
Plasma Interleukin-1 (IL-1), Interleukin- 6 (IL-6),C-reactive protein (CRP) levels will be measured at 07:00 am preoperative and postoperative day 1and day 3.
- Conditions
- Cranial Nerve Diseases
- Being tested
- Group Isolated
- Keywords
- Melatonin, Interleukin, Transcranial, Surgery, Intensive care
- Medical subject headings
- Cranial Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IsolatedOther
Eyes closed with patch and ears plugged between 24:00-06:00
| Study group | Role | What they receive |
|---|---|---|
| Group Isolated | Experimental | Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00) Receives: Other: Group Isolated |
| Group Disrupted | No intervention | Group Disrupted (Group I) (exposed to ambient light and noise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Measured: At preoperative 07:00 am
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Measured: 07:00 am postoprative day 1
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Measured: 07:00 am postoprative day 3
Secondary outcomes (1)
IL-1,IL-6,CRP
serum
Measured: : at 7 o'clock in the morning preoperative day, 7 in the morning on the first postoperative day and 7 in the morning on the third postoperative day hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start3 Sep 2018
- Primary completion8 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cranial Nerve DiseasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomize
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Emine Arık, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659760
- Sponsor's protocol ID
- EmineMelatonin
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2018
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grima NA, Rajaratnam SMW, Mansfield D, Sletten TL, Spitz G, Ponsford JL. Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial. BMC Med. 2018 Jan 19;16(1):8. doi: 10.1186/s12916-017-0995-1.
PubMed 29347988Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Oner S, Ates E. Effects of Sleep Quality on Melatonin Levels and Inflammatory Response after Major Abdominal Surgery in an Intensive Care Unit. Molecules. 2017 Sep 12;22(9):1537. doi: 10.3390/molecules22091537.
PubMed 28895895Osier N, McGreevy E, Pham L, Puccio A, Ren D, Conley YP, Alexander S, Dixon CE. Melatonin as a Therapy for Traumatic Brain Injury: A Review of Published Evidence. Int J Mol Sci. 2018 May 22;19(5):1539. doi: 10.3390/ijms19051539.
PubMed 29786658Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
PubMed 23825812
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03659760
- Acronym / sponsor ID
- EmineMelatonin
- Conditions
- Cranial Nerve Diseases
- Keywords
- Melatonin, Interleukin, Transcranial, Surgery, Intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 6 Sep 2018 (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.
Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory.
In this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery
Detailed description
Patients with Glasgow coma scale (GKS) >14, American Society of Anesthesiologist (ASA) I-III, intensive care patients underwent transcranial surgery will be included
Patients will be randomly allocated by a computer generated random numbers list into two groups.
Patients with sleep disruptions (Group I) (exposed to ambient light and noise) and Patients without sleep disruptions (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Melatonin levels will be measured by urine 6-sulfatoxymelatonin (a-MT6) levels, which is a product of melatonin degradation at 07:00 am preoperative and postoperative day 1 and day 3.
Plasma Interleukin-1 (IL-1), Interleukin- 6 (IL-6),C-reactive protein (CRP) levels will be measured at 07:00 am preoperative and postoperative day 1and day 3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomize
| Arm | Type | Receives |
|---|---|---|
| Group Isolated | Experimental | Other: Group IsolatedGroup Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00) |
| Group Disrupted | No intervention | –Group Disrupted (Group I) (exposed to ambient light and noise) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3
- Glasgow Coma Scale(GCS) >14
Key exclusion criteria (4 listed)
- Glasgow Coma Scale(GCS) <14
- Patients who do not understand the questions, not awake
- Patient who treated with hormones
- Patient with infection or inflammatory disease
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 |
|---|---|---|
| Group IsolatedEyes closed with patch and ears plugged between 24:00-06:00 | Other | Group Isolated |
Primary outcome
Melatonin level
Time frame: At preoperative 07:00 am
Melatonin will be measured urine 6-sulphatoxymelatonin
Melatonin level
Time frame: 07:00 am postoprative day 1
Melatonin will be measured urine 6-sulphatoxymelatonin
Melatonin level
Time frame: 07:00 am postoprative day 3
Melatonin will be measured urine 6-sulphatoxymelatonin
1 secondary outcome
IL-1,IL-6,CRP
Time frame: : at 7 o'clock in the morning preoperative day, 7 in the morning on the first postoperative day and 7 in the morning on the third postoperative day hour
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 11 Feb 2025.
- Background: PubMed 29347988Grima NA, Rajaratnam SMW, Mansfield D, Sletten TL, Spitz G, Ponsford JL. Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial. BMC Med. 2018 Jan 19;16(1):8. doi: 10.1186/s12916-017-0995-1.
- Background: PubMed 28895895Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Oner S, Ates E. Effects of Sleep Quality on Melatonin Levels and Inflammatory Response after Major Abdominal Surgery in an Intensive Care Unit. Molecules. 2017 Sep 12;22(9):1537. doi: 10.3390/molecules22091537.
- Background: PubMed 29786658Osier N, McGreevy E, Pham L, Puccio A, Ren D, Conley YP, Alexander S, Dixon CE. Melatonin as a Therapy for Traumatic Brain Injury: A Review of Published Evidence. Int J Mol Sci. 2018 May 22;19(5):1539. doi: 10.3390/ijms19051539.
- Background: PubMed 23825812Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
- Individual participant dataSharing planned: Undecided
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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.
Emine Arık principal investigator
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Isolated in people with Cranial Nerve Diseases, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 11 Feb 2025. 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 Turkey (Türkiye). 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?
Melatonin level (time frame: At preoperative 07:00 am). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659760, which also lists 4 linked publications.
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 11 Feb 2025.