Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Total Sleep Time
研究概览
简要总结
Human centric lighting (HCL) is a technology that supports the body's circadian rhythm, as it can stimulate the sleep triggering hormone, melatonin, to improve sleep hygiene over standard lighting (SL), and promote recuperative sleep for a timely return-to-duty. In intensive care units, exposure to HCL has improved sleep measures. However, the effect in the medical surgical (MS) environment is unknown. The purpose of this study is to assess the feasibility of study procedures in MS setting and conduct a preliminary evaluation of the effect of light on inpatient sleep. Recruitment started November 2020 through April 2021. Data analysis is pending.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Patient who is an active duty service member, GS Civilian, Dependent or Retiree affiliated with the Army, Air Force or Navy.
- •Patient who is informed by provider or anticipates being admitted for at least two nights.
- •Patient who can read and speak English fluently (since surveys are not translated in any other language).
排除标准
- •Patient with visual impairment which cannot be corrected with glasses or contact lenses such as complete blindness, (defined as inability to see light), or partial blindness (defined as very limited vision) such as patients with history of cataracts.
- •Patient taking an oral medication for sleep.
- •Patient receiving radioactive ionization treatment.
- •Patient who requires isolation or palliative care.
- •Patient recovering from head/neck or oral maxillofacial surgery that would impede saliva sample collection (i.e. jaw wiring, extensive gauze packing in oral cavity)
- •Patient who reports status as a Department of Defense Contractor at screening.
结局指标
主要结局
Total Sleep Time
时间窗: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.
Dim Light Melatonin Onset - collection
时间窗: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of collecting samples to assess dim light melatonin onset in MS setting, using passive drool saliva sampling.
Sleep Patterns
时间窗: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD).
Patient experience
时间窗: One time - approximately a 5 to 15 minute interview
Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI).
Sleep Efficiency
时间窗: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device.
次要结局
- Dim Light Melatonin Onset - analysis(Collected during participant's inpatient stay, not to exceed 5 days.)
研究者
LTC Pauline Swiger
On-Site Principal Investigator
Landstuhl Regional Medical Center