Insomnia and affect - Insomnia and affect

VU Medisch Centrum, Amsterdam UMC0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- Participants have to be at least 18 years old and less than 70 years old.
•- Additional inclusion criteria for the insomnia group specifically:
•* a diagnosis of insomnia according to the International Classification of Sleep Disorders (ICSD-2)
•* an Insomnia Severity Index score (ISI) *10
•- Additional inclusion criteria for the RCT specifically:
•* a high score on the ISQ (cut-off to be determined).

•- a current clinical diagnosis of major depressive disorder or a diagnosis of major depressive (DSM-4) assessed with the Composite International Diagnostic Interview * Short Form (CIDI-SF)
•- Diagnosed sleep apnea syndrome (OSAS) (AHI >15), restless leg syndrome (RLS) or periodic limb movement (PLMD) (PLMI > 25). Using the screening survey, we will exclude candidates with moderate to very severe RLS according to an IRLS scale score > 15 and candidates with a high risk of OSAS according to the Berlin questionnaire. In candidates suspect for PLMD according to the Duke Structured Interview for Sleep Disorders, the PLMI will be determined from the polysomnographic recordings of the pre-assessment; cases with a PLMI of 25 or more will be advised to consult a sleep specialist.
•- a known eye condition incompatible with light exposure
•- a history of light-induced migraine or epilepsy, or severe side effects to bright light in the past.
•- MRI contraindications such as non-MR compatible metal implants, claustrophobia, pregnancy
•* Current treatment with antidepressant medication
•* Night work or rotating shift-work

发起方

VU Medisch Centrum, Amsterdam UMC