Critical CareHELIA-ICUNCT05556811
HEaling LIght Algorithms for the ICU Patient
A study testing Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2 and Dynamic Light Therapy Device, LSA, 3 in people with Critical Care and Phototherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Critical Care, Phototherapy
- What is being tested?
- Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2 and Dynamic Light Therapy Device, LSA, 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2022to 31 May 2024
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient capable of giving consent or additionally existing legal caregiver/authorized representative in case of non-consenting patients in the intensive care unit
- Male and female patients with age ≥ 18 years
- Expected intensive care unit stay ≥ 5 days
- Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure > 6 hours/day or high flow >30 liters) on the day of ICU admission
Who cannot join
- Participation in other clinical studies during the study period and ten days before
- Patients with psychiatric diseases
- Patients with a history of stroke and known severe residual cognitive deficits
- Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
- Analphabetism
- Anacusis or Hypoacusis with hearing aid device, Amaurosis
Show all 25Show fewer
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- History of sleep-related breathing disorders
- History or suspicion of hypoxic brain damage
- History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
- Patients with an open chest after cardiac surgery
- Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
- The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time
- Severe eye diseases
- History of photoallergic reactions
- History of visually triggered seizures
- Termination criteria:
- Under the following conditions, premature withdrawal of a Patient from the study according to the termination criteria will occur:
- Personal request of the patient/caregiver/authorized representative.
- Any other situation in which, in the opinion of the study physician, continued participation in the clinical trial is not in the best interest of the of the patient
- Subsequent occurrence of an exclusion criterion
- Premature termination of the study or discontinuation of the entire study may be considered because of the following circumstances:
- Decision of the principal investigator in case of unacceptable risks under Benefit-risk consideration
- New (scientific) findings during the term of the clinical study that may compromise the safety of the study participants (positive risk-benefit balance no longer given).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Specific Light Algorithms to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with an application of lower irradiances.
The investigators will further evaluate the impact on delirium prevalence, stress level and general outcome parameters.
Read the detailed description
Circadian disruption affects the majority of ICU patients and has far-reaching effects on organ functioning. At the level of the central nervous system, circadian misalignment facilitates executive cognitive dysfunction and the development of brain disorders such as ICU delirium.
The suprachiasmatic nucleus (SCN) in the hypothalamus serves as the master pacemaker that sets the timing of circadian rhythms by regulating neuronal activity. Its function is determined by environmental factors, especially visible light with a high content of blue light components. Light as a photoperiodic signal has a great impact on the regulation of the epiphyseal melatonin secretion and the entrainment of the day-night rhythm. As a result using light therapy to maintain or entrain circadian rhythm seems to be a promising approach to prevent delirium in critically ill patients. The specific light effect on the rhythmicity of the melatonin levels is to be examined in a randomized controlled study design, which includes the application of three different Light Scheduling Algorithms. In this context a highly specialized light ceiling was installed in two patient treatment rooms. A Light Scheduling Algorithm (LSA) consists of specified values for illuminance [lux] and correlated color temperature (CCT, [kelvin]) for different time points and durations within a 24-hour period. These values are calculated by assessment of photometric light measures with regard to visual light effects as well as non-image-forming functions at the patients bedside.
Patients will be randomly allocated in to 3 treatment groups: (1) LSA-1 (high circadian effective irradiances + blue Light Intervention), (2) LSA-2 (high circadian effective irradiances without blue light intervention) and (3) LSA-3 (standard irradiances, Control Group). All LSAs will be applied to the patient using VitalSky Advanced. For the purpose of validation of efficacy of specific light interventions, blood samples for measurement of melatonin concentration will be collected.
The temporal study sequence is defined by treatment days and measurement series periods (SMAP-1 to SMAP-4, Serum Melatonin Assessment Period). SMAP-1 starts on the first morning at 06:00 a.m. after study inclusion. SMAP-1 through SMAP-4 each define 24-hour periods in which the blood melatonin concentration is determined every 4 hours (6 am, 10 am, 2 pm, 6 pm, 10 pm, 2 am, 6 am). The SMAP-1 is intended to determine the patient's individual melatonin baseline. SMAP-2 to SMAP-4 start only when the patient has reached a stable level of wakefulness (RASS ≥-3 ). It can be assumed that the light intervention will only have an effect on melatonin balance from this level of wakefulness. A total of 4 SMAPs are planned per study patient.
Main Hypothesis:
Ventilated ICU patients receiving increased irradiance lighting may differ in the rhythmicity of serum melatonin concentrations and more frequently exhibit physiologic circadian melatonin secretions compared with patients receiving conventional irradiance lighting.
Secondary Hypotheses:
- Ventilated intensive care patients receiving illumination with increased irradiance and phases of Blue-Enriched White light (BEW) differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with increased irradiance but without BEW.
- Ventilated intensive care patients receiving illumination with increased irradiance and phases with BEW differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with conventional irradiance.
- Ventilated intensive care patients receiving illumination with increased irradiance without phases with BEW differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with conventional irradiance.
- Ventilated intensive care patients receiving increased irradiance lighting and periods of BEW have a lower incidence of delirium than patients receiving conventional irradiance lighting.
- Ventilated intensive care patients receiving increased irradiance lighting and periods of BEW have lower delirium severity than patients receiving conventional irradiance lighting.
- Conditions
- Critical Care, Phototherapy
- Being tested
- Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2, Dynamic Light Therapy Device, LSA, 3
- Keywords
- Light therapy, Melatonin, Critical Care, Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Light Therapy Device, LSA-1Device
Dynamic Light Therapy
Dynamic Light Therapy Device, LSA-2Device
Dynamic Light Therapy
Dynamic Light Therapy Device, LSA, 3Device
Dynamic Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| LSA-1 | Active comparator | Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes Receives: Device: Dynamic Light Therapy Device, LSA-1 |
| LSA-2 | Active comparator | Light Scheduling Algorithm-2 (LSA-2): High circadian effective irradiances without Blue Enriched Light episodes. Receives: Device: Dynamic Light Therapy Device, LSA-2 |
| LSA-3 | Active comparator | Light Scheduling Algorithm-3 (LSA-3): Irradiance levels comparable to conventional hospital lighting (control group). Receives: Device: Dynamic Light Therapy Device, LSA, 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum melatonin concentration
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations
Measured: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).
Secondary outcomes (14)
Prevalence of intensive care unit delirium
Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU), Binary scale (Positive/Negative)
Measured: Participants will be followed up to 6 days after intensive care unit admission
Delirium Severity
Delirium Severity will be measured with the Intensive Care Delirium Screening Checklist (ICDSC). The higher the score the worse - higher score = higher delirium severity(ICDSC)
Measured: Participants will be followed up to 6 days after intensive care unit admission
Depth of Sedation
Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS), -5 to +4, negative scores translates to a higher degree of sedation.
Measured: Participants will be followed up to 6 days after intensive care unit admission
Severity of Pain
Severity of pain will be measured with the Numeric Rating Scale (NRS), or the Visualized Numeric Rating Scale (NRS-V) or the Faces Pain Scale-Revised (FPS-R) or the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non- Intubated (BPS-NI). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome
Measured: Participants will be followed up to 6 days after intensive care unit admission
Patient comfort
Distress thermometer
Measured: Participants will be followed up to 6 days after intensive care unit admission
Duration of mechanical and non-mechanical ventilation
Hours
Measured: Participants will be followed up until ICU discharge
ICU length of stay
Days
Measured: Participants will be followed up until ICU discharge
Hospital length of stay
days
Measured: Participants will be followed up until hospital discharge
Sepsis
Does patient fulfil sepsis criteria (Yes/No)
Measured: Participants will be followed up to 6 days after intensive care unit admission
Septic Shock
Does patient fulfil criteria for septic shock (Yes/No)
Measured: Participants will be followed up to 6 days after intensive care unit admission
Sequential Organ Failure Assessment (SOFA-Score)
Predicts ICU mortality based on lab results and clinical data.
Measured: Participants will be followed up to 6 days after intensive care unit admission
Simplified Acute Physiology Score (SAPS II)
Estimates mortality in ICU patients, comparable to APACHE II.
Measured: Participants will be followed up to 6 days after intensive care unit admission
Therapeutic Intervention Scoring System (TISS-28)
The Simplified Therapeutic Intervention Scoring System TISS-28 consists of 28 items. It is intended to accurately measure the level of care required for a patient in the Intensive Care Unit (ICU)
Measured: Participants will be followed up to 6 days after intensive care unit admission
Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States.
Measured: Participants will be followed up to 6 days after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Sep 2022
- Primary completion15 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alawi Luetz, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556811
- Sponsor's protocol ID
- 20018170
- Acronym
- HELIA-ICU
- Status last verified
- Jun 2024
- First submitted
- 18 Aug 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Specific Light Algorithms to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05556811
- Acronym / sponsor ID
- HELIA-ICU / 20018170
- Conditions
- Critical Care, Phototherapy
- Keywords
- Light therapy, Melatonin, Critical Care, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Sep 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.
The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with an application of lower irradiances.
The investigators will further evaluate the impact on delirium prevalence, stress level and general outcome parameters.
Detailed description
Circadian disruption affects the majority of ICU patients and has far-reaching effects on organ functioning. At the level of the central nervous system, circadian misalignment facilitates executive cognitive dysfunction and the development of brain disorders such as ICU delirium.
The suprachiasmatic nucleus (SCN) in the hypothalamus serves as the master pacemaker that sets the timing of circadian rhythms by regulating neuronal activity. Its function is determined by environmental factors, especially visible light with a high content of blue light components. Light as a photoperiodic signal has a great impact on the regulation of the epiphyseal melatonin secretion and the entrainment of the day-night rhythm. As a result using light therapy to maintain or entrain circadian rhythm seems to be a promising approach to prevent delirium in critically ill patients. The specific light effect on the rhythmicity of the melatonin levels is to be examined in a randomized controlled study design, which includes the application of three different Light Scheduling Algorithms. In this context a highly specialized light ceiling was installed in two patient treatment rooms. A Light Scheduling Algorithm (LSA) consists of specified values for illuminance [lux] and correlated color temperature (CCT, [kelvin]) for different time points and durations within a 24-hour period. These values are calculated by assessment of photometric light measures with regard to visual light effects as well as non-image-forming functions at the patients bedside.
Patients will be randomly allocated in to 3 treatment groups: (1) LSA-1 (high circadian effective irradiances + blue Light Intervention), (2) LSA-2 (high circadian effective irradiances without blue light intervention) and (3) LSA-3 (standard irradiances, Control Group). All LSAs will be applied to the patient using VitalSky Advanced. For the purpose of validation of efficacy of specific light interventions, blood samples for measurement of melatonin concentration will be collected.
The temporal study sequence is defined by treatment days and measurement series periods (SMAP-1 to SMAP-4, Serum Melatonin Assessment Period). SMAP-1 starts on the first morning at 06:00 a.m. after study inclusion. SMAP-1 through SMAP-4 each define 24-hour periods in which the blood melatonin concentration is determined every 4 hours (6 am, 10 am, 2 pm, 6 pm, 10 pm, 2 am, 6 am). The SMAP-1 is intended to determine the patient's individual melatonin baseline. SMAP-2 to SMAP-4 start only when the patient has reached a stable level of wakefulness (RASS ≥-3 ). It can be assumed that the light intervention will only have an effect on melatonin balance from this level of wakefulness. A total of 4 SMAPs are planned per study patient.
Main Hypothesis:
Ventilated ICU patients receiving increased irradiance lighting may differ in the rhythmicity of serum melatonin concentrations and more frequently exhibit physiologic circadian melatonin secretions compared with patients receiving conventional irradiance lighting.
Secondary Hypotheses:
- Ventilated intensive care patients receiving illumination with increased irradiance and phases of Blue-Enriched White light (BEW) differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with increased irradiance but without BEW.
- Ventilated intensive care patients receiving illumination with increased irradiance and phases with BEW differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with conventional irradiance.
- Ventilated intensive care patients receiving illumination with increased irradiance without phases with BEW differ in the rhythmicity of serum melatonin concentrations compared with patients receiving illumination with conventional irradiance.
- Ventilated intensive care patients receiving increased irradiance lighting and periods of BEW have a lower incidence of delirium than patients receiving conventional irradiance lighting.
- Ventilated intensive care patients receiving increased irradiance lighting and periods of BEW have lower delirium severity than patients receiving conventional irradiance lighting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LSA-1 | Active comparator | Device: Dynamic Light Therapy Device, LSA-1Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes |
| LSA-2 | Active comparator | Device: Dynamic Light Therapy Device, LSA-2Light Scheduling Algorithm-2 (LSA-2): High circadian effective irradiances without Blue Enriched Light episodes. |
| LSA-3 | Active comparator | Device: Dynamic Light Therapy Device, LSA, 3Light Scheduling Algorithm-3 (LSA-3): Irradiance levels comparable to conventional hospital lighting (control group). |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient capable of giving consent or additionally existing legal caregiver/authorized representative in case of non-consenting patients in the intensive care unit
- Male and female patients with age ≥ 18 years
- Expected intensive care unit stay ≥ 5 days
- Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure > 6 hours/day or high flow >30 liters) on the day of ICU admission
Key exclusion criteria (25 listed)
- Participation in other clinical studies during the study period and ten days before
- Patients with psychiatric diseases
- Patients with a history of stroke and known severe residual cognitive deficits
- Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
- Analphabetism
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 |
|---|---|---|
| Dynamic Light Therapy Device, LSA-1Dynamic Light Therapy | Device | LSA-1 |
| Dynamic Light Therapy Device, LSA-2Dynamic Light Therapy | Device | LSA-2 |
| Dynamic Light Therapy Device, LSA, 3Dynamic Light Therapy | Device | LSA-3 |
Primary outcome
Change in serum melatonin concentration
Time frame: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations
14 secondary outcomes
Prevalence of intensive care unit delirium
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Delirium Severity
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Depth of Sedation
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Severity of Pain
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Patient comfort
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Duration of mechanical and non-mechanical ventilation
Time frame: Participants will be followed up until ICU discharge
ICU length of stay
Time frame: Participants will be followed up until ICU discharge
Hospital length of stay
Time frame: Participants will be followed up until hospital discharge
Sepsis
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Septic Shock
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Sequential Organ Failure Assessment (SOFA-Score)
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Simplified Acute Physiology Score (SAPS II)
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Therapeutic Intervention Scoring System (TISS-28)
Time frame: Participants will be followed up to 6 days after intensive care unit admission
Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)
Time frame: Participants will be followed up to 6 days after intensive care unit admission
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 13 Jun 2024.
- Website of Research GroupLink provided by the sponsor.
- Website of DepartmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Critical Care
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Mechanical Ventilation, Critical Care
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2 and Dynamic Light Therapy Device, LSA, 3 in people with Critical Care and Phototherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 25 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 13 Jun 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 Germany. 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?
Change in serum melatonin concentration (time frame: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).). 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 13 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.