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临床试验/NCT04751019
NCT04751019已完成不适用

The Use of Amber Glasses in Improving Sleep and Reducing the Use of Hypnotic Medication in an Inpatient Mental Health Setting: Pilot Study

Surrey and Borders Partnership NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
The difference in the use of hypnotic medication as compared with existing data from a similar population.

研究概览

简要总结

The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

详细描述

Sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. Moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (Baglioni, 2016). We hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.A prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. Data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. Hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. Medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. Each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age over 18 years
  • Male or female gender
  • Presentation of mental illness (of psychotic nature, severe depression or anxiety)
  • Able to provide informed consent

排除标准

  • Patient does not consent
  • High risk assessment of self-harm or harm to others

结局指标

主要结局

The difference in the use of hypnotic medication as compared with existing data from a similar population.

时间窗: 4 weeks

Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment (PSQI) tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period. These historic admissions will be matched for diagnosis.

次要结局

  • Change in sleep quality as measured by a point score change in the PSQI.(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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