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Completed

NCT Number: NCT02420275

Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Raymond Poincare

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

"Luminette",Lucimed Belgium

Device

THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 30 minutes

    Fatigue measure by fatigue severity scale

Secondary outcomes

  1. Epworth slumber scale

    Time frame: 30 minutes

    Subjective Slumber measured by Epworth slumber scale

  2. Analog visual scales

    Time frame: 10 minutes

    subjective slumber measured by Epworth slumber scale

  3. Psychomotor Vigilance Task

    Time frame: 15 minutes

    vigilance measured by Psychomotor Vigilance Task

  4. P300

    Time frame: 30 minutes

    Cognitive evoked potential measure by P300

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Fondation Garches

Registry information

Official study title

Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas

Acronym: phototrauma

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2015
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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