Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
Getting enough sleep is important for maximizing health and well-being. When it comes to health, sleep is as vital as regular exercise and eating a balanced diet. Not getting enough sleep can lead to health problems like heart attacks, diabetes, and even cancer. Since individuals with psoriasis have these same health problems, getting better sleep may help to keep them happier and healthier. This study will look at how individuals with psoriasis sleep and if their sleep is different than indivuduals without psoriasis.
详细描述
A growing body of literature has revealed that individuals with psoriasis are more likely to report sleep disturbance when compared to the general population. The cross-sectional study presented here will allow the investigators to objectively and rigorously measure sleep architecture in psoriasis patients and compare it to healthy controls, If sleep dysfunction is confirmed in this population, then clinical interventions such as screening for sleep disturbance or promoting sleep hygiene could lead to meaningful improvements in patients' health, longevity, and overall quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patients with a diagnosis of moderate to severe plaque type psoriasis confirmed by the principal investigator. Moderate to severe psoriasis will be defined as affected BSA ≥3%. Healthy controls will be age and sex matched (see below) subjects with no prior or current history of psoriasis.
- •Are at least 18 years of age
- •Psoriasis has been stable over the last 3 months
- •Psoriasis is either untreated or treated only with topicals at the current time (see exclusion criteria for washout times)
- •Subjectively reported poor sleep quality using the Pittsburg Sleep Quality Index (PSQI) (defined as a global score >5)
- •Fluent in English
- •Demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent
排除标准
- •Patients with guttate, erythrodermic, or pustular psoriasis subtypes
- •Having a previous diagnosis of obstructive sleep apnea (OSA) or another medically defined sleep disorder or fall into the intermediate or high-risk groups for having OSA as calculated by the STOP-BANG questionnaire
- •Subjects who have used the following treatments for psoriasis: phototherapy (UVB) in the last 2 weeks, photochemotherapy (PUVA) in the last 4 weeks, oral systemic treatments in the last 4 weeks, biologic immunomodulating agents in the last 12 weeks, or have had exposure to any other investigational drug/device within 30 days prior to study entry
- •Subjects who have used any over the counter or prescription sleep aids within five half-lives of the agent in question.
结局指标
主要结局
Sleep efficiency
时间窗: Average over 3 consecutive nights of sleep
Sleep efficiency is defined as the percentage of time spent asleep while in bed.
次要结局
- Sleep onset latency(Average over 3 consecutive nights of sleep)
- Total sleep time(Average over 3 consecutive nights of sleep)
- Wake after sleep onset(Average over 3 consecutive nights of sleep)