Clinical trial NCT02420275: Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue
Official title: Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Brain Injury
Keywords: brain injury
blue enriched withe bright light therapy
sequel fatigue
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2015-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.

Detailed description: After a BI , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by blue enriched withe bright light in order to improve fatigue and quality of life.

The main objective is to decrease fatigue and the secondary objectives are to improve quality of life,decrease daytime sleepiness and increase vigilance.

This is a randomized clinical trial with 2 groups blue enriched withe bright light versus nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl estimate the fatigue severity scale score , the quality of life the score (SF12), the sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will included patient with severe BI more than six months after the BI.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 30 minutes
Secondary outcomes:
measure: Epworth slumber scale
timeFrame: 30 minutes
measure: Analog visual scales
timeFrame: 10 minutes
measure: Psychomotor Vigilance Task
timeFrame: 15 minutes
measure: P300
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: RAYMOND POINCARE HOSPITAL
name: MARIA ANTONIA QUERA SALVA, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RAYMOND POINCARE HOSPITAL
name: SARAH HARTLEY, MD
role: STUDY_CHAIR
References:
citation: Quera Salva MA, Azabou E, Hartley S, Sauvagnac R, Leotard A, Vaugier I, Pradat Diehl P, Vallat-Azouvi C, Barbot F, Azouvi P. Blue-Enriched White Light Therapy Reduces Fatigue in Survivors of Severe Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E78-E85. doi: 10.1097/HTR.0000000000000500.