Critical IllnessPhase 4NCT07691996
Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
A Phase 4 study testing Melatonin in people with Critical Illness and ICU, run by Rutgers, The State University of New Jersey.
Trial summary
This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ICU, ICU Hospitalization
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older, admitted to the ICU
- Expected length of stay of at least 48 hours
- Not mechanically ventilated
- Able to take oral medications.
- Hemodynamically stable as determined by the treating ICU physician
- Able to provide informed consent or have consent provided by a legally -authorized representative.
Who cannot join
- Mechanically ventilated
- Currently using melatonin prior to ICU admission,
- Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.
- Pregnant or lactating individuals
- Those individuals with a comfort measures-only status
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.
- Conditions
- Critical Illness, ICU, ICU Hospitalization, Melatonin, Sleep
- Being tested
- Melatonin
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
patients in this arm will recieve melatonin
| Study group | Role | What they receive |
|---|---|---|
| Melatonin arm | Experimental | 3mg Melatonin will be administered orally to all subjects. Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency as measured by total sleep time over time in bed
These measures are obtained from the sleep profiler. Higher sleep efficiency is better.
Measured: From enrollment to the end of 48 hours of the last subject's participation in the study
, Total sleep time in hours and minutes
These measures are obtained from the sleep profiler.
Measured: From enrollment to the end of 48 hours of the last subject's participation in the study
, Delta to Theta ratio
These measures are obtained from the sleep profiler Higher delta to Theta ratio is better
Measured: From enrollment to the end of 48 hours of the last subject's participation in the study
, Arousal Index
These measures are obtained from the sleep profiler. Lower arousal index is better
Measured: From enrollment to the end of 48 hours of the last subject's participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jag Sunderram, MD, Rutgers, The State University of New Jersey
- Investigators
- Jag Sunderram, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691996
- Sponsor's protocol ID
- Pro2025002445
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2026
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
- ClinicalTrials.gov ID
- NCT07691996
- Acronym / sponsor ID
- Pro2025002445
- Conditions
- Critical Illness, ICU, ICU Hospitalization, Melatonin, Sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Jul 2026 (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.
This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin arm | Experimental | Drug: Melatonin3mg Melatonin will be administered orally to all subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older, admitted to the ICU
- Expected length of stay of at least 48 hours
- Not mechanically ventilated
- Able to take oral medications.
- Hemodynamically stable as determined by the treating ICU physician
Key exclusion criteria (5 listed)
- Mechanically ventilated
- Currently using melatonin prior to ICU admission,
- Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.
- Pregnant or lactating individuals
- Those individuals with a comfort measures-only status
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 |
|---|---|---|
| Melatoninpatients in this arm will recieve melatonin | Drug | Melatonin arm |
Primary outcome
Sleep Efficiency as measured by total sleep time over time in bed
Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler. Higher sleep efficiency is better.
, Total sleep time in hours and minutes
Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler.
, Delta to Theta ratio
Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler Higher delta to Theta ratio is better
, Arousal Index
Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler. Lower arousal index is better
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
Jag Sunderram principal investigator
Rutgers Robert Wood Johnson Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Critical Illness and ICU, run by Rutgers, The State University of New Jersey.
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 6 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jag Sunderram, MD (732-235-7038, sunderja@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency as measured by total sleep time over time in bed (time frame: From enrollment to the end of 48 hours of the last subject's participation in the study). The study lists 4 primary outcomes in all. 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 Jul 2026.