Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
研究概览
简要总结
Objectives and evaluation criteria:
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.
The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Research plan and procedure:
Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:
- Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
- Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.
Number of research participants:
As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test.
Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week.
Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Research duration:
Inclusion period: 5 days, Monday to Friday Participation period: 3 days (from day 0 to day 2) Study duration: 7 days
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
- •Anticipated hospital stay > 48 hours
排除标准
- •Patient hospitalized for more than 24 hours,
- •Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
- •No mastery of French
- •Patient hospitalized for sleep pathology (evaluation or treatment),
- •Patient hospitalized in an intensive psychiatric care room,
- •Patients hospitalized under duress,
- •Patient opposition,
- •Patient under guardianship or curatorship.
结局指标
主要结局
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
时间窗: 3 days
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments. The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale. Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization: * Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale. * Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale. NB: - Spiegel score ranks from 0 to 30 (Questionnaire)
次要结局
- Participants numbers repartitions within departments categories following their spiegel score(3 days)
- Distributions of the number of participants within hospital facility types following their Spiegel score(3 days)
- Distribution of the number of participants in the different room types according to their Spiegel score(3 days)
- Distributions of the number of participants by age group following Spiegel score(3 days)
- Distribution of number of participants by gender and Spiegel score(3 days)
- Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).(3 days)