Controlled Clinical Trial Between Sleep-Wake Quality and Adjustment of Nocturnal Medical Orders in Hospitalized Patients at Hospital Clinica Nova
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Objetive changes in REM sleep
研究概览
简要总结
The goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards.
The main questions it aims to answer are:
Does reducing non-urgent nocturnal medical interruptions increase total sleep time and REM duration? Does improving sleep continuity enhance subjective sleep quality and physiologic stability (heart rate, blood pressure)? Researchers will compare the intervention group (patients under an adjusted nighttime order protocol) with the control group (standard hospital care) to determine whether reorganizing nighttime medical routines improves objective and perceived sleep outcomes.
Participants will:
Wear a Fitbit Sense® device to continuously monitor objective sleep parameters across three hospital nights.
Complete the Pittsburgh Sleep Quality Index (PSQI) at admission and discharge to assess subjective sleep quality.
Undergo standard nighttime vital sign evaluations according to their assigned study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients admitted within the past 24 hours
- •Aged 18-65 years
- •Hospitalized in the general ward of Hospital Clínica Nova
- •Minimum in-hospital stay ≥ 3 days
- •Visual Analog Scale for pain < 3
- •Glasgow Coma Scale > 13
排除标准
- •Visual, hearing, intellectual, or cognitive disability
- •History of sleep disorders or obstructive sleep apnea
- •Use of antidepressants, anxiolytics, hypnotics, or CNS stimulants
- •Hemodynamic instability upon admission or during hospitalization
- •Patients transferred from the ICU
研究组 & 干预措施
Control
干预措施: Standard (Behavioral)
Intervention
干预措施: Sleep enhancement intervention (Behavioral)
结局指标
主要结局
Objetive changes in REM sleep
时间窗: 3 days
Change in REM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions, and between groups with and without the intervention.
Subjective sleep quality changes
时间窗: 3 nights
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated instrument that evaluates subjective sleep quality across seven components. PSQI global scores will be compared between the intervention and control groups to determine whether reducing nocturnal interruptions is associated with improved subjective sleep-wake quality.
Objetive changes in REM sleep
时间窗: 3 days
Change in REM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions, and between groups with and without the intervention.
Subjective sleep quality changes
时间窗: 3 nights
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated instrument that evaluates subjective sleep quality across seven components. PSQI global scores will be compared between the intervention and control groups to determine whether reducing nocturnal interruptions is associated with improved subjective sleep-wake quality.
次要结局
- Differences in sleep-wake quality between male and female participants(3 nights)
- Association between sleep-wake quality and participant age(3 nights)
- Association between sleep-wake quality and body mass index (BMI).(3 nights)
- Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups(3 nights)
- Objective changes in NREM sleep(3 nights)
- Differences in sleep-wake quality between male and female participants(3 nights)
- Association between sleep-wake quality and participant age(3 nights)
- Association between sleep-wake quality and body mass index (BMI).(3 nights)
- Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups(3 nights)
- Objective changes in NREM sleep(3 nights)
研究者
Maria Elena Romero Ibarguengoitia
Principal Investigator
Hospital Clinica Nova