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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT02420275 |
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Date of registration:
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10/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue
phototrauma |
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Scientific title:
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Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas |
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Date of first enrolment:
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May 11, 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02420275 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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SARAH HARTLEY, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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RAYMOND POINCARE HOSPITAL |
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Name:
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MARIA ANTONIA QUERA SALVA, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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RAYMOND POINCARE HOSPITAL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Severe brain injury patients more than 6 months after the trauma
- Out of the phase of post-traumatic amnesia (score in Galveston Orientation and Amnesia
Test (GOAT) upper to 75)
- Initial score on the Glasgow coma scale inferior or equal to 8 within the first 24
hours after brain injury, except sedation
- Age from 18 to 65 years old
- Fatigue severity score ( FSS) superior or equal to 4 and/or a score on the sleepiness
Epworth scale superior or equal to 10 and/or a score to the quality questionnaire of
sleep of Pittsburg > in 5
- Having given a writing informed consent
- Registered on the Social Security
Exclusion Criteria:
- Non-stabilized psychiatric neurological affection and/or endocrine diseases or drug
addiction
- Major depression diagnosed with the "MINI" depression scale
- Cognitive, behavioural or motor disorders incompatible with use of phototherapy
glasses
- Night workers or transméridien journey in the last month
- Chronic fatigue syndrome before the accident
- Deafness
- Major obesity (BMI > 33)
- High risk of apnea syndrome in the Berlin questionnaire
- Consumption of long half-l hypnotics or stimulants
- Treatments with antidepressants are tolerated if the dose is stable during all the
participation on approval and for at least one month before the inclusion.
- Eye lesion, in particular of the retina
- Photosensibility
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Brain Injury
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Intervention(s)
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Device: "Luminette",Lucimed Belgium
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Other: placebo
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Primary Outcome(s)
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Fatigue Severity Scale
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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P300
[Time Frame: 30 minutes]
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Epworth slumber scale
[Time Frame: 30 minutes]
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Analog visual scales
[Time Frame: 10 minutes]
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Psychomotor Vigilance Task
[Time Frame: 15 minutes]
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Secondary ID(s)
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2015-A000321-48
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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