The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorThe Hong Kong Polytechnic University
About this trial
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 standardized 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 to 60 years
Right-hand and right-foot dominant
Disqualifiers
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
Trial population
Healthy Adult with or without insomnia
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Eccentric exercise
Other interventionEccentric exercise
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Insomnia1 intervention
Group B: Healthy contry1 intervention
Trial outcomes
Primary outcomes
1
Sleep diary: Total Sleep Time
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.
Time frame
Day 0 to Day 142
Sleep diary: Sleep Onset Latency (SOL)
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.
Time frame
Day 0 to Day 143
Sleep diary: Wake After Sleep Onset (WASO)
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.
Time frame
Day 0 to Day 144
Sleep diary: Sleep Efficiency (SE)
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.
Time frame
Day 0 to Day 14Secondary outcomes
1
Muscle damage severity: Muscle pain
Muscle pain will be measured by an 11-point NRS, with 0 represents "no pain" and 10 indicating "worst imaginable pain". The Outcome will be recorded at rest, reach for the floor with knees straight, and during a validated hamstring provocative manoeuvre, the "taking-off shoe" test.
Time frame
Day 0 to Day 142
Muscle damage severity: Muscle soreness
Muscle soreness will be measured by an 7-point Likert scale, with 0= A complete absence of soreness," 1 = "A light soreness in the muscle felt only when touched/a vague ache," 2 = "A moderate soreness felt only when touched/a slight persistent pain," 3 = "A light muscle soreness when walking up and down stairs," 4 = "A light muscle soreness when walking on flat surface," 5 = "A moderate muscle soreness, stiffness, or weakness when walking," 6 = "A severe muscle soreness, stiffness, or weakness that limits my ability to move."
Time frame
Day 0 to Day 143
Sleep Questionnaires: the Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a 5-point Likert scale (0 to 4). The total score ranges from 0 to 28, with higher scores indicating greater severity of insomnia
Time frame
Day 0 and Day 74
Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report questionnaire that evaluates sleep quality and disturbances over a 1-month time interval. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3. The sum of these seven component scores yields a global PSQI score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame
Day 0 and Day 7Sponsors and contacts
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Source ClinicalTrials.gov