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临床试验/NCT07198477
NCT07198477尚未招募不适用

Sleep Disturbances and Their Association With Serum Magnesium Level in Patients With Major Depressive Disorder

Assiut University0 个研究点目标入组 90 人开始时间: 2026年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
change in the level of serum magnesium level

研究概览

简要总结

This cross-sectional study investigates the relationship between serum magnesium levels and the presence of sleep disturbances among patients with major depressive disorder (MDD).

详细描述

Major depressive disorder is a highly prevalent psychiatric condition often accompanied by disabling sleep disturbances, including insomnia and hypersomnia. Evidence suggests that magnesium, a vital trace element involved in neurotransmission, stress response, and circadian regulation, may play a crucial role in both mood and sleep. Low serum magnesium levels have been linked to increased depressive symptom severity and disturbed sleep quality. This study seeks to explore whether hypomagnesemia can serve as a biological contributor to sleep dysfunction in MDD. By employing the Beck Depression Inventory-II (BDI-II) and the Pittsburgh Sleep Quality Index (PSQI), as well as laboratory measurement of serum magnesium levels, the study aims to determine whether lower magnesium is significantly associated with greater depressive burden and poor sleep outcomes. The findings may help validate magnesium as a biomarker for early screening and risk stratification in psychiatric care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed diagnosis of major depressive disorder
  • •age 18 years and older
  • •Ability to complete questionnaires (BDI-II and PSQI; validated Arabic versions)
  • •Willing to participate and provide informed consent

排除标准

  • •hronic renal failure or metabolic disorders affecting magnesium balance
  • •Current use of medications known to significantly interfere with serum magnesium (e.g., long-term diuretics, proton pump inhibitors) unless stable and documented
  • •Presence of other comorbid psychiatric disorders
  • •Cognitive impairment or language difficulties preventing questionnaire completion

结局指标

主要结局

change in the level of serum magnesium level

时间窗: Baseline

Serum magnesium concentration (mmol/L) measured by atomic absorption spectrophotometry for the patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alzahraa Aref Fouad

resident at the Neuropsychiatry department

Assiut University

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