The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep diary: Total Sleep Time
研究概览
简要总结
This study investigates how acute exercise-induced muscular pain affects sleep quality and sleep architecture in people with insomnia compared to healthy sleepers.
Sleep disturbances and pain often influence each other, creating a negative cycle; however, it remains unclear how acute muscle pain-such as delayed-onset muscle soreness (DOMS) after strenuous exercise-alters continuous sleep parameters and pain sensitivity differently in clinical insomnia populations versus healthy controls.
Participants will be divided into two groups: individuals with clinical insomnia and age- and sex-matched healthy sleepers. Both groups will undergo a standardised exercise protocol designed to safely induce temporary, acute muscular soreness (DOMS). Objective sleep parameters (measured via wrist actigraphy) and subjective sleep parameters (measured via sleep diaries), will be monitored before and after the pain induction. The primary goal is to determine whether individuals with insomnia experience greater sleep disruption and altered pain recovery trajectories following an acute painful event compared to healthy individuals.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 years
- •Right-hand and right-foot dominant
排除标准
- •History of any chronic musculoskeletal pain or presence of existing pain during recruitment
- •Previous major injuries or surgery involving the lower limbs
- •Sleep disorders other than insomnia
- •Clinically diagnosed psychiatric disorders
- •Contraindications to vigorous exercise identified through the physical activity readiness questionnaire (PAR-Q)
- •Work night shifts or rotating shift schedules
研究组 & 干预措施
Insomnia
干预措施: Eccentric exercise (Other)
Healthy contry
干预措施: Eccentric exercise (Other)
结局指标
主要结局
Sleep diary: Total Sleep Time
时间窗: Day 0 to Day 14
Assessed using a daily consensus sleep diary. Total Sleep Time is calculated as the total time spent asleep, derived from the total time in bed (bedtime to wake time) minus sleep onset latency and wake after sleep onset. Higher values indicate longer sleep duration.
Sleep diary: Sleep Onset Latency (SOL)
时间窗: Day 0 to Day 14
Assessed using a daily consensus sleep diary. Sleep Onset Latency is the estimated time (in minutes) it takes to fall asleep after turning off the lights. Lower values indicate better sleep onset.
Sleep diary: Wake After Sleep Onset (WASO)
时间窗: Day 0 to Day 14
Assessed using a daily consensus sleep diary. WASO is calculated as the total duration of wakefulness (in minutes) between initial sleep onset and final awakening, derived from the number of night awakenings multiplied by their average duration. Lower values indicate better sleep continuity.
Sleep diary: Sleep Efficiency (SE)
时间窗: Day 0 to Day 14
Assessed using a daily consensus sleep diary. Sleep Efficiency is calculated as the percentage of time in bed spent asleep: \[(Total Sleep Time / Total Time in Bed) × 100\]. Total Sleep Time is derived from total time in bed (time between bedtime and rise time) minus sleep onset latency and nocturnal wakefulness (calculated from the number and duration of night awakenings). Scores range from 0% to 100%, with higher percentages indicating better sleep quality.
Actigraphy: Total Sleep Time (TST)
时间窗: Day 0 to Day 14
Measured objectively using a wrist-worn ActiGraph accelerometer and validated sleep-scoring algorithms. Total Sleep Time is defined as the total amount of time spent sleeping between bedtime and rise time. Higher values indicate longer sleep duration.
Actigraphy: Sleep Onset Latency (SOL)
时间窗: Day 0 to Day 14
Measured objectively using a wrist-worn ActiGraph accelerometer. Sleep Onset Latency is the time (in minutes) between the initial bedtime (lights out) and the onset of continuous sleep detected by the algorithm. Lower values indicate faster sleep onset and better sleep initiation.
Actigraphy: Wake After Sleep Onset (WASO)
时间窗: Day 0 to Day 14
Measured objectively using a wrist-worn ActiGraph accelerometer. WASO is defined as the total number of minutes spent awake after initial sleep onset and before final awakening, as determined by epoch-by-epoch movement counts. Lower values indicate better sleep continuity and fewer night awakenings.
Actigraphy: Sleep Efficiency (SE)
时间窗: Day 0 to Day 14
Measured objectively using a wrist-worn ActiGraph accelerometer. Sleep Efficiency is calculated as the percentage of time in bed spent asleep: \[(Total Sleep Time / Total Time in Bed) × 100\]. Values range from 0% to 100%, with higher percentages indicating better sleep quality and efficiency.
次要结局
- Muscle damage severity: Muscle pain(Day 0 to Day 14)
- Muscle damage severity: Muscle soreness(Day 0 to Day 14)
- Sleep Questionnaires: the Insomnia Severity Index (ISI)(Day 0 and Day 7)
- Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)(Day 0 and Day 7)
- Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)(Day 0, Day 7, and Day 9)
- Psychological measurement: Pain Catastrophizing Scale (PCS)(Day 0, Day 7, and Day 9)
- Psychological measurement: Fear of Pain Questionnaire (FPQ-9)(Day 0, Day 7, and Day 9)
- Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)(Day 0, Day 7, and Day 9)
- Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Day 0 and Day 7)