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NCT02732288 · ClinicalTrials.gov registry record · NA
Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury
A NA study, sponsored by Rockefeller University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02732288: Clinical Trial NA study, sponsored by Rockefeller University.
NCT02732288 is a NA study that was terminated before completion, run by Rockefeller University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02732288, a NA study, was terminated before completion, sponsored by Rockefeller University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Patients with severe brain injuries often have slow accumulating recoveries of function. In ongoing studies, we have discovered that elements of electrical activity during sleep may correlate with the level of behavioral recovery observed in patients. It is unknown whether such changes are causally linked to behavioral recovery. Sleep processes are, however, associated with several critical processes supporting the cellular integrity of neurons and neuronal mechanisms associated with learning and synaptic modifications. These known associations suggest the possibility that targeting the normalization of brain electrical activity during sleep may aid the recovery process. A well-studied mechanism organizing the pattern of electrical activity that characterizes sleep is the body's release of the substance melatonin. Melatonin is produced in the brain and released at a precise time during the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep process each day. Ongoing research by other scientists has demonstrated that providing a small dose of melatonin can improve the regular pattern of sleep and help aid sleep induction. Melatonin use has been shown to be effective in the treatment of time change effects on sleep ("jet lag") and mood disturbances associated with changes in daily light cues such as seasonal affective disorder. We propose to study the effects of melatonin administration in patients with severe structural brain injuries and disorders of consciousness. We will measure the patient's own timing of release of melatonin and provide a dose of melatonin at night to test the effects on the electrical activity of sleep over a three month period. In addition to brain electrical activity we will record sleep behavioral data and physical activity using activity monitors worn by the patients. Patient subjects in this study will be studied twice during the three month period in three day inpatient visits where they will undergo video mo
Interventions
- DIETARY_SUPPLEMENT melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-05 |
| Est. Completion | 2018-06-19 |
| Phase | NA |
Why NCT02732288 stopped before completion
NCT02732288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which melatonin is the first listed.
NCT02732288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02732288 about?
NCT02732288 is a clinical study titled "Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury". Patients with severe brain injuries often have slow accumulating recoveries of function. In ongoing studies, we have discovered that elements of electrical activity during sleep may correlate with the level of behavioral recovery observed in patients. It is unknown whether such changes are causally ...
What is the current status of trial NCT02732288?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2016-05. Estimated completion is 2018-06-19.
What interventions are being tested in trial NCT02732288?
The interventions under investigation include: melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02732288?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02732288's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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