Sleep Disturbance Prevalence In Bullous Pemphigoid Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To examine the prevalence of sleep disturbances in patients with bullous pemphigoid compared to a control group using the Insomnia Severity Index (ISI) questionnaire annexed to this protocol.
研究概览
简要总结
Bullous pemphigoid (BP) is the most common autoimmune blistering disorder. The incidence of BP has increased due to increased life expectancy, particularly in developed countries, which can be associated with multiple geriatric comorbidities and polypharmacy.
Epidemiological studies of BP have shown that the incidence ranges from 2.5 to 42.8 cases/million/year in European countries.
BP affects older adults with multiple comorbidities, primarily neurological diseases such as multiple sclerosis, dementia, Parkinson's disease, epilepsy, and stroke, which are usually diagnosed before BP.
Diagnosis is based on clinical suspicion combined with immunopathological investigations. The clinical chronological course is characterized by relapses and remissions. The goals of PB treatment are to stop the development of new skin lesions, healing of old lesions, and symptomatic therapy.
详细描述
The patient's physical and psychological state can be seriously affected by the disease itself or by the side effects of treatment. These effects could lead to a decrease in the patient's functional capacity and increase the burden, stress, and isolation of the patient and their family. These significant effects may be underestimated by healthcare professionals, which may be partly explained by the paucity of published reports on this particular problem.
Sleep is a fundamental, restorative, physiological, and neurobiological state that consumes approximately one-third of our lives. Sleep is carefully regulated by multiple processes, including homeostatic sleep and the circadian system. Itching and pain can significantly reduce patients' quality of life and sleep.
BP can be a stressful experience and places a significant burden on patients. Patients often have difficulty coping with new changes in daily tasks. Specific daily activities such as housekeeping, dressing, and showering can also be complicated. As a result, patients may experience frustration, depression, low self-esteem, and a reduced quality of life.
Furthermore, pain, itching, and discomfort can negatively impact sleep, mood, and enjoyment of life, further contributing to depression and frustration in these patients.
No studies have been published on the effect of bullous pemphigoid on sleep quality or the prevalence of sleep disturbances in bullous pemphigoid patients, except for a recent study published in January 2019 in the journal Clinical and Experimental Dermatology. This study was conducted in Poland and included a total of 31 participants. The researchers assessed sleep quality using a sleep monitor (Actisleep+) worn in the dominant hand. This study confirmed that PB patients have very poor sleep quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Adult Patient
- •Patients: Bullous Pemphigoid: Newly diagnosed by:
- •Rash suggestive of Bullous Pemphigoid
- •Histology: Subepidermal bulla or margination of eosinophils along the dermoepidermal junction (DEJ)
- •Controls: Patient with Basal Cell Carcinoma, Squamous Cell Carcinoma, Seborrheic Keratosis, Actinic Keratosis, or Other Benign Skin Tumor. We selected the control group from these patients because these dermatological conditions do not affect sleep quality.
- •Mini Mental Status Examination (MMS) score > 20
- •No Formulated Opposition
排除标准
- •Protected Adult
- •Advanced Dementia Syndrome
结局指标
主要结局
To examine the prevalence of sleep disturbances in patients with bullous pemphigoid compared to a control group using the Insomnia Severity Index (ISI) questionnaire annexed to this protocol.
时间窗: Enrollment visit and month 1
The Insomnia Severity Index (ISI), which is a brief instrument designed to assess the severity of both daytime and daytime components of insomnia. The total ISI score is interpreted as follows: * No insomnia (0-7) * Subthreshold insomnia (8-14) * Moderate insomnia (15-21) * Severe insomnia (22-28)
次要结局
- Determination of disease-related predictors of sleep disorders(Enrollment visit and month 1)