Disorders of ConsciousnessNCT02930213
The Core Body Temperature Rhythms: Distinguishing MCS From UWS
An observational study of Disorders of Consciousness, run by Jing Wang.
Trial summary
In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h . Read more about this study
- Who is it for?
- Ages 39 to 69 years
- Conditions the study is for
- Disorders of Consciousness
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- How long will I take part?
- 8 Days
- Phase
- Observational
- 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 39 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators chossen patients with UWS or MCS.The subjects include 4 UWS and 3 MCS.
Who may be able to join
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Who cannot join
- premorbid neurology antecedent
- patients in coma or vegetative state
- patients < 1 months after the acute brain injury
About this study
Official title: The Core Body Temperature Rhythms:A Promising Indicator of Distinguishing MCS From UWS
In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .
Read the detailed description
Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (>24h ), which is also called free-running period.
Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.
Researchers expected to see the difference between MCS and UWS.
- Conditions
- Disorders of Consciousness
- Keywords
- unresponsive wakefulness syndrome, minimally conscious state, circadian rhythms, free-running period
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the continuous external auditory canal temperature
VS patients have core body temperature periods which are longer than 24 hours; whereas MCS patients are shorter than 24 hours.
Measured: Continuous temperature measurements for 168 hours (8days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Jing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Wang, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930213
- Sponsor's protocol ID
- CX2014128
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Core Body Temperature Rhythms:A Promising Indicator of Distinguishing MCS From UWS
- ClinicalTrials.gov ID
- NCT02930213
- Acronym / sponsor ID
- CX2014128
- Conditions
- Disorders of Consciousness
- Keywords
- unresponsive wakefulness syndrome, minimally conscious state, circadian rhythms, free-running period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jing WangUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Oct 2016 (estimated)
- 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.
In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .
Detailed description
Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (>24h ), which is also called free-running period.
Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.
Researchers expected to see the difference between MCS and UWS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 8 Days
Who may qualify
- Ages
- 39 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators chossen patients with UWS or MCS.The subjects include 4 UWS and 3 MCS.
Key inclusion criteria (3 listed)
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Key exclusion criteria (3 listed)
- premorbid neurology antecedent
- patients in coma or vegetative state
- patients < 1 months after the acute brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring the continuous external auditory canal temperature
Time frame: Continuous temperature measurements for 168 hours (8days)
VS patients have core body temperature periods which are longer than 24 hours; whereas MCS patients are shorter than 24 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 12 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness, run by Jing Wang.
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 3 inclusion and 3 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 12 Oct 2016. 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.
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?
Measuring the continuous external auditory canal temperature (time frame: Continuous temperature measurements for 168 hours (8days)). 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 12 Oct 2016.