SleepNCT04666142
The Effect of Light on Sleep Quality and Physiological Parameters in Individuals in Intensive Care Unit
A study of Sleep and Light, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The research was carried out in randomized controlled experimental type in order to determine the effect of light in ICU on patients' sleep quality and physiological parameters. The cases were assigned to the experimental and control groups according to the simple randomization method. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2019to 28 Dec 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Not having a problem in terms of consciousness and sense organs
- A score of 9 or above on the Glaskow Coma Scale (GCS),
- Richmond Agitation-Sedation Scale (RASS) score was determined as -1,0,1.
Who cannot join
- Be under the age of 18
- Having a problem in terms of consciousness and sense organs,
- A GCS score below 9,
- Receiving inotropic support,
- Being fully sedated,
- Having a chronic disease such as chronic heart disease, dementia, psychosis,
- Identified as having severe brain injury.
Trial locations and contacts
1 site in 1 country.
About this study
The research was carried out in randomized controlled experimental type in order to determine the effect of light in ICU on patients' sleep quality and physiological parameters. The cases were assigned to the experimental and control groups according to the simple randomization method.
The research universe; Between May 2019 and December 2019, sick individuals who were admitted to the 5 isolation rooms in the Reanimation Intensive Care clinic in the education and research hospital in Istanbul were formed. The research sample is; As a result of the power made for the study to be experimentally designed; a total of 148, with a minimum of 74 for each group. In collecting data; Patient Information Form, Numerical Pain Rating Scale, Richards Campbell Sleep Scale, Glaskow Coma Scale, Richmond Agitation Sedation Scale, Bedside Monitors were used to measure physiological parameters. The data obtained as a result of the research were made using the package program named SPSS (IBM SPSS Statistics 24).
Read the detailed description
Sleep causes temporary, partial and periodic interruption of the organism's interaction with the environment, is a physiological condition that affects many systems. That sleep activity is a vital and important activity for individuals.They emphasized and sleep; the alternating state of inertia and inertia, around the human a situation where they do not respond to the events that took place. initiation and maintenance through the function of many cortical and subcortical brain regions. People sleep on average one third of their lives They spend it. The sleep of a normal adult person consists of night sleep and It lasts an average of 7 to 9 hours, with a sleep time of four to six 90 to 100 minutes. Non-REM (NREM) and REM sleep change cyclically. In the sleep-wake cycle in man, the most basic and determinant is the circadian rhythm. Circadian The rhythm refers to changes in the physiological and biological processes of the organism for about a day. The main center that regulates the circadian rhythm is located in the anterior hypothalamus as a double structure. suprachiasmatic nucleus (SKN). Light is the most important rhythm editor. Other regulators are social and are physical activities. Florence Nightingale and Virgina Henderson in love and day rhythm; defined the patient as two important factors in supporting the health of the individual. In the regulation of the circadian rhythm, the light and dark cycle in the external environment is important. The synthesis and release of melatonin is stimulated in the dark at night, and during the day by the effect of light It is suppressed. N-acetyl transferase (NAT) enzyme is effective in melatonin formation. Melatonin The main task of the hormone is to protect the biological rhythm of the body. In this context; lighting, circadian rhythm and sleep are related.
Health care institutions and especially intensive care units, in terms of physical environment and lighting the patient can affect the circadian rhythm of the individual, change the release of melatonin and as a result can affect sleep patterns and cognitive performance. In our country, in terms of physical environment lighting, it does not support circadian rhythms. As a result, sick individuals in the ICU are asleep The therapeutic effect of sleep because they spend a significant amount of time they need to be awake can not benefit sufficiently. In addition, in the ICU, many There is a factor. These factors are; pain, physical condition, drug therapy, fear of death, environmental noise, pleasant non-smells, invasive interventions, loss of privacy and family disability. In the study of, the greatest stress of the sick individuals in the ICU One of the causes was found to be sleeping problems. In the literature, especially in health care institutions In patients with ICU inpatient, sleep activity has a negative effect on both duration and quality. shows that it is affected In admission to the ICU, when environmental factors are not suitable, the patient especially the sleep activity of the individual is impaired and this process occurs even after the patient is discharged from YBU, can continue. One of the biggest reasons for this; Physical environment and lighting of ICUs in terms of disruption of circadian rhythms of sick individuals. The presence of night light suppresses the level of melatonin, which is normally the highest at night. Melatonin level is accepted as an indicator of circadian rhythm. Artificial lighting is a known factor in the disruption of the circadian rhythm. Sick individuals in the ICU, 24 hours it is exposed to artificial light throughout a cycle. Artificial lighting, health of the sick individual health care to help professionals continue their care and treatment practices It is applied at high levels for 24 hours in institutions such as ICU. Its as a result, daylight is often obscured / eliminated in ICUs and artificial lighting are added. Researches conducted, unnatural night disruption of circadian rhythms with illumination causes health problems related to sleep activity. It is also sufficient and relaxing non-sleep, negatively affects the immune system, wound healing process and cognitive functions of the sick individual. It affects in the same direction, increases the level of stress and delays its recovery. Sick individuals in the ICU are concerned with serious illnesses or injuries and care and treatment. The illness of the symptoms lies. Today, long-term health of an illness or injury in an ICU It is known to cause problems. Some of these problems are sleep problems due to lighting and circadian rhythm disturbances. our Country Study to determine the effect of environmental factors related to lighting on sleep problems in ICU There is. Nurses who continue the care and treatment of sick individuals in ICU, diagnosing problems early, identifying primary nursing diagnoses, existing stressors important role such as reduction, ensuring the necessary environmental regulation to create a therapeutic environment, and they have responsibilities. In this context, this research is based on YBU. to determine the effect of light on sleep quality and physiological parameters in individuals and nursing will be carried out to guide its applications.
- Being tested
- Comparison of the personal characteristics of the experimental and control groups, Light applied experimental group, control group treated with standard intensive care lighting
- Keywords
- Sleep Quality, Light, Intensive Care Unit
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the personal characteristics of the experimental and control groupsOther
General characteristics of the individuals in the experimental and control groups were compared.
Light applied experimental group, control group treated with standard intensive care lightingOther
According to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control"
| Study group | Role | What they receive |
|---|---|---|
| Individual Characteristics of the Individuals in the Experimental and Control Groups | Active comparator | The personal characteristics of the individuals included in the study were examined. Receives: Other: Comparison of the personal characteristics of the experimental and control groups |
| Disease Characteristics of the Individuals in Experimental and Control Groups | Active comparator | The intensive care experience of the individuals included in the study, their status of receiving respiratory support, and the reason for staying in the intensive care unit were explained. Receives: Other: Comparison of the personal characteristics of the experimental and control groups |
| Distribution of Findings Regarding Sleep Activity of the Individuals in Both Groups | Active comparator | The personal characteristics of the individuals in the experimental and control groups regarding sleep were examined. Receives: Other: Comparison of the personal characteristics of the experimental and control groups |
| Comparison of the Individuals in the experimental and control groups after 24 hours of sleep | Active comparator | The effect of light after 24 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined. Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting |
| Comparison of physiological parameters of individuals in both groups after 24 hours | Active comparator | Comparison of the physiological parameters of the individuals in the experimental and control groups 24 hours after their admission to the ICU. Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting |
| Comparison of the Sleep Times of the Individuals in Both Groups 48 Hours After Intensive Care | Active comparator | The effect of light after 48 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined. Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting |
| Comparison of physiological parameters of individuals in both groups after 48 hours | Active comparator | Comparison of the physiological parameters of the individuals in the experimental and control groups 48 hours after their admission to the ICU. Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting |
| Distribution of Total Sleep Times of the Individuals in the Experimental and Control Groups | Active comparator | The sleep times of the individuals in both groups were compared Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep time with light intervention in experimental and control groups in the intensive care unit
A recirculating lighting system was installed in the isolation room for the experimental group in line with evidence-based design principles. Light fixture 120 cm from the floor. high and light shining up. The system was set up to operate at varying levels of 9 lights, illumination for 24 hours. No application other than the standard lighting system of the ICU was applied to the individuals in the control group. Actiwatch device was placed on the arm of the sick individuals. Thanks to this device, the sleep time of the individuals was recorded.
Measured: After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.
Secondary outcomes (4)
The effect of light on the patient's systolic and diastolic blood pressure in the experimental and control groups in the intensive care unit.
The systolic and diastolic blood pressure of the individual was recorded hourly by the investigator through the bedside monitoring system for 48 hours after admission to the ICU.
Measured: The systolic and diastolic blood pressure of the patient who was admitted to the intensive care unit was recorded for 48 hours.
The effect of light on patient's heart rate in intensive care unit in experimental and control groups.
The heart rate of the individual was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.
Measured: The heart rate of the patient, who was admitted to the intensive care unit, was recorded for 48 hours.
The effect of light on patient's respiratory rate in intensive care unit in experimental and control groups.
The respiration of the patient was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.
Measured: The respiration of the patient who was admitted to intensive care unit was recorded for 48 hours.
The effect of light on the patient's body temperature in the intensive care unit in the experimental and control groups.
The body temperature of the patient was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.
Measured: The body temperature of the patient who was admitted to intensive care unit was recorded for 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start2 May 2019
- Primary completion5 Jul 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control"
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Pamuk, Istanbul University - Cerrahpasa
- Investigators
- kübra pamuk, graduate, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666142
- Sponsor's protocol ID
- U1111-1260-6250
- Other IDs
- Kübra pamuk
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light on Sleep Quality and Physiological Parameters in Individuals in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04666142
- Acronym / sponsor ID
- U1111-1260-6250
- Keywords
- Sleep Quality, Light, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 14 Dec 2020 (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 research was carried out in randomized controlled experimental type in order to determine the effect of light in ICU on patients' sleep quality and physiological parameters. The cases were assigned to the experimental and control groups according to the simple randomization method.
The research universe; Between May 2019 and December 2019, sick individuals who were admitted to the 5 isolation rooms in the Reanimation Intensive Care clinic in the education and research hospital in Istanbul were formed. The research sample is; As a result of the power made for the study to be experimentally designed; a total of 148, with a minimum of 74 for each group. In collecting data; Patient Information Form, Numerical Pain Rating Scale, Richards Campbell Sleep Scale, Glaskow Coma Scale, Richmond Agitation Sedation Scale, Bedside Monitors were used to measure physiological parameters. The data obtained as a result of the research were made using the package program named SPSS (IBM SPSS Statistics 24).
Detailed description
Sleep causes temporary, partial and periodic interruption of the organism's interaction with the environment, is a physiological condition that affects many systems. That sleep activity is a vital and important activity for individuals.They emphasized and sleep; the alternating state of inertia and inertia, around the human a situation where they do not respond to the events that took place. initiation and maintenance through the function of many cortical and subcortical brain regions. People sleep on average one third of their lives They spend it. The sleep of a normal adult person consists of night sleep and It lasts an average of 7 to 9 hours, with a sleep time of four to six 90 to 100 minutes. Non-REM (NREM) and REM sleep change cyclically. In the sleep-wake cycle in man, the most basic and determinant is the circadian rhythm. Circadian The rhythm refers to changes in the physiological and biological processes of the organism for about a day. The main center that regulates the circadian rhythm is located in the anterior hypothalamus as a double structure. suprachiasmatic nucleus (SKN). Light is the most important rhythm editor. Other regulators are social and are physical activities. Florence Nightingale and Virgina Henderson in love and day rhythm; defined the patient as two important factors in supporting the health of the individual. In the regulation of the circadian rhythm, the light and dark cycle in the external environment is important. The synthesis and release of melatonin is stimulated in the dark at night, and during the day by the effect of light It is suppressed. N-acetyl transferase (NAT) enzyme is effective in melatonin formation. Melatonin The main task of the hormone is to protect the biological rhythm of the body. In this context; lighting, circadian rhythm and sleep are related.
Health care institutions and especially intensive care units, in terms of physical environment and lighting the patient can affect the circadian rhythm of the individual, change the release of melatonin and as a result can affect sleep patterns and cognitive performance. In our country, in terms of physical environment lighting, it does not support circadian rhythms. As a result, sick individuals in the ICU are asleep The therapeutic effect of sleep because they spend a significant amount of time they need to be awake can not benefit sufficiently. In addition, in the ICU, many There is a factor. These factors are; pain, physical condition, drug therapy, fear of death, environmental noise, pleasant non-smells, invasive interventions, loss of privacy and family disability. In the study of, the greatest stress of the sick individuals in the ICU One of the causes was found to be sleeping problems. In the literature, especially in health care institutions In patients with ICU inpatient, sleep activity has a negative effect on both duration and quality. shows that it is affected In admission to the ICU, when environmental factors are not suitable, the patient especially the sleep activity of the individual is impaired and this process occurs even after the patient is discharged from YBU, can continue. One of the biggest reasons for this; Physical environment and lighting of ICUs in terms of disruption of circadian rhythms of sick individuals. The presence of night light suppresses the level of melatonin, which is normally the highest at night. Melatonin level is accepted as an indicator of circadian rhythm. Artificial lighting is a known factor in the disruption of the circadian rhythm. Sick individuals in the ICU, 24 hours it is exposed to artificial light throughout a cycle. Artificial lighting, health of the sick individual health care to help professionals continue their care and treatment practices It is applied at high levels for 24 hours in institutions such as ICU. Its as a result, daylight is often obscured / eliminated in ICUs and artificial lighting are added. Researches conducted, unnatural night disruption of circadian rhythms with illumination causes health problems related to sleep activity. It is also sufficient and relaxing non-sleep, negatively affects the immune system, wound healing process and cognitive functions of the sick individual. It affects in the same direction, increases the level of stress and delays its recovery. Sick individuals in the ICU are concerned with serious illnesses or injuries and care and treatment. The illness of the symptoms lies. Today, long-term health of an illness or injury in an ICU It is known to cause problems. Some of these problems are sleep problems due to lighting and circadian rhythm disturbances. our Country Study to determine the effect of environmental factors related to lighting on sleep problems in ICU There is. Nurses who continue the care and treatment of sick individuals in ICU, diagnosing problems early, identifying primary nursing diagnoses, existing stressors important role such as reduction, ensuring the necessary environmental regulation to create a therapeutic environment, and they have responsibilities. In this context, this research is based on YBU. to determine the effect of light on sleep quality and physiological parameters in individuals and nursing will be carried out to guide its applications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- According to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control"
| Arm | Type | Receives |
|---|---|---|
| Individual Characteristics of the Individuals in the Experimental and Control Groups | Active comparator | Other: Comparison of the personal characteristics of the experimental and control groupsThe personal characteristics of the individuals included in the study were examined. |
| Disease Characteristics of the Individuals in Experimental and Control Groups | Active comparator | Other: Comparison of the personal characteristics of the experimental and control groupsThe intensive care experience of the individuals included in the study, their status of receiving respiratory support, and the reason for staying in the intensive care unit were explained. |
| Distribution of Findings Regarding Sleep Activity of the Individuals in Both Groups | Active comparator | Other: Comparison of the personal characteristics of the experimental and control groupsThe personal characteristics of the individuals in the experimental and control groups regarding sleep were examined. |
| Comparison of the Individuals in the experimental and control groups after 24 hours of sleep | Active comparator | Other: Light applied experimental group, control group treated with standard intensive care lightingThe effect of light after 24 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined. |
| Comparison of physiological parameters of individuals in both groups after 24 hours | Active comparator | Other: Light applied experimental group, control group treated with standard intensive care lightingComparison of the physiological parameters of the individuals in the experimental and control groups 24 hours after their admission to the ICU. |
| Comparison of the Sleep Times of the Individuals in Both Groups 48 Hours After Intensive Care | Active comparator | Other: Light applied experimental group, control group treated with standard intensive care lightingThe effect of light after 48 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined. |
| Comparison of physiological parameters of individuals in both groups after 48 hours | Active comparator | Other: Light applied experimental group, control group treated with standard intensive care lightingComparison of the physiological parameters of the individuals in the experimental and control groups 48 hours after their admission to the ICU. |
| Distribution of Total Sleep Times of the Individuals in the Experimental and Control Groups | Active comparator | Other: Light applied experimental group, control group treated with standard intensive care lightingThe sleep times of the individuals in both groups were compared |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- Not having a problem in terms of consciousness and sense organs
- A score of 9 or above on the Glaskow Coma Scale (GCS),
- Richmond Agitation-Sedation Scale (RASS) score was determined as -1,0,1.
Key exclusion criteria (7 listed)
- Be under the age of 18
- Having a problem in terms of consciousness and sense organs,
- A GCS score below 9,
- Receiving inotropic support,
- Being fully sedated,
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 |
|---|---|---|
| Comparison of the personal characteristics of the experimental and control groupsGeneral characteristics of the individuals in the experimental and control groups were compared. | Other | Disease Characteristics of the Individuals in Experimental and Control Groups, Distribution of Findings Regarding Sleep Activity of the Individuals in Both Groups, Individual Characteristics of the Individuals in the Experimental and Control Groups |
| Light applied experimental group, control group treated with standard intensive care lightingAccording to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control" | Other | Comparison of physiological parameters of individuals in both groups after 24 hours, Comparison of physiological parameters of individuals in both groups after 48 hours, Comparison of the Individuals in the experimental and control groups after 24 hours of sleep, Comparison of the Sleep Times of the Individuals in Both Groups 48 Hours After Intensive Care, Distribution of Total Sleep Times of the Individuals in the Experimental and Control Groups |
Primary outcome
Change in sleep time with light intervention in experimental and control groups in the intensive care unit
Time frame: After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.
A recirculating lighting system was installed in the isolation room for the experimental group in line with evidence-based design principles. Light fixture 120 cm from the floor. high and light shining up. The system was set up to operate at varying levels of 9 lights, illumination for 24 hours. No application other than the standard lighting system of the ICU was applied to the individuals in the control group. Actiwatch device was placed on the arm of the sick individuals. Thanks to this device, the sleep time of the individuals was recorded.
4 secondary outcomes
The effect of light on the patient's systolic and diastolic blood pressure in the experimental and control groups in the intensive care unit.
Time frame: The systolic and diastolic blood pressure of the patient who was admitted to the intensive care unit was recorded for 48 hours.
The effect of light on patient's heart rate in intensive care unit in experimental and control groups.
Time frame: The heart rate of the patient, who was admitted to the intensive care unit, was recorded for 48 hours.
The effect of light on patient's respiratory rate in intensive care unit in experimental and control groups.
Time frame: The respiration of the patient who was admitted to intensive care unit was recorded for 48 hours.
The effect of light on the patient's body temperature in the intensive care unit in the experimental and control groups.
Time frame: The body temperature of the patient who was admitted to intensive care unit was recorded for 48 hours.
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 16 Dec 2020.
- Individual participant dataSharing planned: No
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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.
kübra pamuk, graduate principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sleep and Light, run by Istanbul University - Cerrahpasa 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 4 inclusion and 7 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 16 Dec 2020. 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?
Change in sleep time with light intervention in experimental and control groups in the intensive care unit (time frame: After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.). 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 16 Dec 2020.