Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial

Mild traumatic brain injury (TBI) is associated with persistent sleep-wake dysfunction, including insomnia and circadian rhythm disruption, which can exacerbate functional outcomes including mood, pain, and quality of life. Present therapies to treat sleep-wake disturbances in those with TBI (e.g., cognitive behavioral therapy for insomnia) are limited by marginal efficacy, poor patient acceptability, and/or high patient/provider burden. Thus, this study aimed to assess the feasibility and preliminary efficacy of morning bright light therapy, to improve sleep in Veterans with TBI (NCT03578003). Thirty-three Veterans with history of TBI were prospectively enrolled in a single-arm, open-label intervention using a lightbox (~10,000 lux at the eye) for 60-minutes every morning for 4-weeks. Pre- and post-intervention outcomes included questionnaires related to sleep, mood, TBI, post-traumatic stress disorder (PTSD), and pain; wrist actigraphy as a proxy for objective sleep; and blood-based b...轻度创伤性脑损伤（mild traumatic brain injury, TBI）与持续性睡眠-觉醒功能障碍相关，包括失眠及昼夜节律紊乱，此类障碍可恶化情绪、疼痛与生活质量等功能结局。当前用于治疗TBI患者睡眠-觉醒紊乱的疗法（如失眠认知行为疗法）受限于疗效有限、患者接受度欠佳，以及/或患者与医护人员负担过重等问题。为此，本研究旨在评估晨间强光疗法用于改善创伤性脑损伤退伍军人睡眠状况的可行性与初步疗效（临床试验注册号：NCT03578003）。本研究前瞻性纳入33名有创伤性脑损伤病史的退伍军人，开展一项单臂开放标签干预试验：受试者每日晨间使用光疗灯（眼部照度约10000勒克斯）进行60分钟光疗，持续4周。干预前后的评估指标包括：睡眠、情绪、创伤性脑损伤、创伤后应激障碍（post-traumatic stress disorder, PTSD）及疼痛相关问卷；以腕部体动记录仪作为客观睡眠的替代检测手段；以及血液相关……