Multicenter Study on the Role of Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia Through Circadian Phase Modification.

Some evidence indicates that circadian rhythm may play a role in the pathophysiology of insomnia disorder. This single-blind randomized controlled multicentre prospective study aims to evaluate the possible therapeutic effect of light therapy in modulating the clinical phenotype of patients affected by chronic primary and comorbid insomnia, through the modification of the circadian phase.

STUDY DESIGN AND METHODS

With regard to the study in question, it should be noted that:

• the study is a prospective multicentre randomized single-blind controlled trial
• the duration of the study is expected to be 3 years with a duration of enrollment of 2 and a half years and a minimum clinical follow-up of 3 months

The study will be divided into two evaluations, an initial evaluation (Time 0, T0) where the patients will be enrolled and all the measurements required before treatment with light therapy will be performed, and a final evaluation after 6 weeks of treatment with light therapy effective or sham (Time 1, T1), where the measurements performed at T0 will be repeated. Both assessments will be performed at the Sleep Medicine outpatient clinic.