Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Sleep-modulating Drugs in the Recovery of Patients With Disorders of Consciousness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948660
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
The research contains three parts. Part 1: To explore the evaluating and prognostic values of electroencephalography sleep cycle combined with the serum melatonin and orexin level of patients with disorders of consciousness; Part 2: To assess the efficacy of the wake-promoting function of zolpidem tartrate in comotase patients; Part 3: To assess the efficacy of the wake-promoting function of melatonin in comotase patients.

Condition or disease Intervention/treatment Phase
Consciousness Disorders Other: zolpidem tartrate Other: melatonin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : October 2016
Estimated Primary Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
acute consciousness disorders group

Duration time of coma <= 3 weeks.

This group will receive sleep EEG monitoring, serum melatonin and orexin level testing, and Zolpidem Tartrate Tablets or melatonin treatment.

Other: zolpidem tartrate
Other: melatonin
chronic consciousness disorders group

Duration time of coma > 3 weeks.

This group received sleep EEG monitoring, serum melatonin and orexin testing, and Zolpidem Tartrate Tablets or melatonin treatment.

Other: zolpidem tartrate
Other: melatonin



Primary Outcome Measures :
  1. The Coma Recovery Scale-Revised [ Time Frame: 3 months after enrollment ]

Secondary Outcome Measures :
  1. Glasgow-Pittsburgh cerebral performance categories [ Time Frame: 3 months after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glasgow Coma Scale score <=8
  • vital signs are stable
  • no history use of sedative or anesthetics

Exclusion Criteria:

  • premorbid history of developmental, psychiatric, or neurological illness resulting in documented functional disabilities up to time of the injury
  • severe coexisting systemic disease with a limited life expectancy
  • EEG showing non-convulsive status epilepticus

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): NCT02948660


Contacts
Layout table for location contacts
Contact: Wen Jiang, Doctor 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Xiai Yang, Master 86-029-84771319 yxa2004.7@163.com

Locations
Layout table for location information
China, Shaanxi
Department of Neurology, Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Xiai Yang, Master    +86 029 84771319    yxa2004.7@163.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
Layout table for investigator information
Study Director: Wen Jiang, doctor Department of Neurology, Xijing Hospital, Fourth Military Medical University

Layout table for additonal information
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02948660     History of Changes
Other Study ID Numbers: 81571262
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Zolpidem
GABA-A Receptor Agonists
GABA Agonists
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
GABA Agents
Neurotransmitter Agents