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Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury

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ClinicalTrials.gov Identifier: NCT02732288
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Nicholas Schiff, Rockefeller University

Brief 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 monitoring and sampling of brain electrical activity using pasted electrodes ("EEG"), hourly saliva sampling for one day, and participation in behavioral testing.

Condition or disease Intervention/treatment Phase
Disorders of Consciousness Dietary Supplement: melatonin Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury
Study Start Date : May 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin, brain injured patients
Melatonin 3mg, orally, at 8pm, daily for 3 months
Dietary Supplement: melatonin
After measuring the subject's own timing of release of melatonin, subjects will be provided a dose of melatonin at 8pm to test the effects on the electrical activity of sleep, measured using electroencephalography. The same intervention will be given to healthy, non-brain injured controls.

Experimental: Healthy volunteers
Melatonin 3mg, orally, at 8pm
Dietary Supplement: melatonin
After measuring the subject's own timing of release of melatonin, subjects will be provided a dose of melatonin at 8pm to test the effects on the electrical activity of sleep, measured using electroencephalography. The same intervention will be given to healthy, non-brain injured controls.




Primary Outcome Measures :
  1. Changes in in sleep/wake architecture following melatonin administration as assessed by time domain analysis of sleep EEG [ Time Frame: baseline, 3 months ]

Secondary Outcome Measures :
  1. quantitative measures of EEG spectral content [ Time Frame: baseline, 3 months ]
  2. Changes in wakeful behavior level [ Time Frame: baseline, 3 months ]
    Scales include: Coma Recovery Scale (CRS) and Confusion Assessment Protocol (CAP)

  3. Activity levels captured by Actigraph device [ Time Frame: baseline, 3 months ]
    Actigraph is a wearable motion detector used to monitor and track activity and sleep.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for subjects:

  • Subject's legally authorized representative must be fluent in English
  • Subject must have been able to speak English prior to the brain injury occurrence
  • Subject must have previously participated in the NSC-0764 study at Rockefeller University Hospital or New York Presbyterian-Cornell
  • Subject must be diagnosed with a severe nonprogressive brain injury
  • Subject must be medically stable
  • Subject must be between 18 and 65 years of age
  • Male and female subjects accepted
  • Subject must have previously participated in studies with EEG data that identify elements of sleep architecture (evidence of components of at least 1 of the following: Stage 2 features (e.g. spindles K complexes, or vertex waves) or stage 3 features (e.g. slow waves), including the NSC-0764 study, and this data must be available to the PI.

HEALTHY VOLUNTEERS: case matched to the study population +/- 5 years; fluent in English; ability to sit still for several consecutive hours; must sleep normal hours consistently (approximately 10 pm - about 6 am) and not be a shift worker

Exclusion Criteria for subjects:

  • Refractory generalized seizures
  • Ventilator dependency
  • Evidence of Alzheimer's Disease or dementia preinjury
  • Currently taking melatonin
  • Dialysis dependency
  • Premorbid neuropsychiatric history (Axis I requiring prior hospitalization)
  • History of severe asthma (requiring hospitalization)
  • Participation in any investigational trial within 30 days prior to enrollment in this study
  • History of any sleep disorder or restless leg syndrome pre-injury
  • Medical history, physical examination, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study

HEALTHY VOLUNTEERS: current or past medical history of any neurological disease or cardiovascular disease, sleep disorder, teeth grinding or restless leg syndrome (RLS); taking any medications with any neurologic effects, any medical condition that disrupts sleep; participation in NSC-0764; Body Mass Index (BMI) > 30 kg/m2;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732288


Contacts
Contact: Jennifer Hersh, MBE 646-962-8032 jeh2015@med.cornell.edu

Locations
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nicholas Schiff, MD Weill Cornell Medical College/ Rockefeller University

Publications:

Responsible Party: Nicholas Schiff, Principal Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT02732288     History of Changes
Other Study ID Numbers: NSC-0894
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants