NL-OMON44172已完成不适用
Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial. - Bright light therapy in reumatoid arthritis.
niversiteit Leiden0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •I. Patient is on stable disease-modifying antirheumatic drug (DMARD) therapy for at least 3 months before the start of the study.
- •II. Disease Activity Scale (DAS) 28 <= 3.2.
- •III. Patient has abnormal feelings of fatigue as assessed by Checklist Individual Strength (CIS)-8 >= 27 (indicates abnormal levels of fatigue) (Bultmann et al., 2000).
排除标准
- •I. Patient*s treatment consists of glucocorticoids, melatonin, or photosensitizing medication (e.g. amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, and/or temoporfin (Anderson et al., 2016)) and/or changed in type or dose within the last 3 months before start of the study.
- •II. Patient*s medical conditions or recent medical events potentially compromises the effects of safety of light therapy (e.g. psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, severe acute suicidality, history of light-induced migraine or epilepsy or severe side effects to light therapy in the past, and/or pre-existing ocular abnormalities (e.g. glaucoma, retinitis, retinopathy, and/or macular degeneration)).
- •III. Midsleep on free days corrected for sleep deficit build up during working days (as measured with the Munich Chronotype Questionnaire) > 4:00h which reflected patients with a late chronotype.
- •IV. Patient has been involved in light therapy within 1 year before the start of the study.
- •V. Patient has been unable to maintain a regular sleep schedule (e.g. due to shift work) within 1 year before start of the study and/or expected during the study.
- •VI. Patient has travelled within three months before study start and/or has the plan to travel during the study to a time zone that deviates two or more hours from the Netherlands; and
- •VII. Patient or partner is pregnant or has a wish for pregnancy during the therapy period or gives breastfeeding.
研究者
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