Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls

14 september 2026 uppdaterad av: The Hong Kong Polytechnic University

The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls: a Case-control Study

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Healthy Adult with or without insomnia

Beskrivning

Inclusion Criteria:

  • Adults aged 18 to 60 years
  • Right-hand and right-foot dominant

Exclusion Criteria:

  • 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
  • Pregnant

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Insomnia
Övrig: Eccentric exercise
Eccentric hamstring exercise
Healthy contry
Övrig: Eccentric exercise
Eccentric hamstring exercise

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sleep diary: Total Sleep Time
Tidsram: 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.
Day 0 to Day 14
Sleep diary: Sleep Onset Latency (SOL)
Tidsram: 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.
Day 0 to Day 14
Sleep diary: Wake After Sleep Onset (WASO)
Tidsram: 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.
Day 0 to Day 14
Sleep diary: Sleep Efficiency (SE)
Tidsram: 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.
Day 0 to Day 14
Actigraphy: Total Sleep Time (TST)
Tidsram: 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.
Day 0 to Day 14
Actigraphy: Sleep Onset Latency (SOL)
Tidsram: 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.
Day 0 to Day 14
Actigraphy: Wake After Sleep Onset (WASO)
Tidsram: 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.
Day 0 to Day 14
Actigraphy: Sleep Efficiency (SE)
Tidsram: 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.
Day 0 to Day 14

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Muscle damage severity: Muscle pain
Tidsram: Day 0 to Day 14
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.
Day 0 to Day 14
Muscle damage severity: Muscle soreness
Tidsram: Day 0 to Day 14
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."
Day 0 to Day 14
Sleep Questionnaires: the Insomnia Severity Index (ISI)
Tidsram: Day 0 and Day 7
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
Day 0 and Day 7
Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
Tidsram: Day 0 and Day 7
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.
Day 0 and Day 7
Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
Tidsram: Day 0, Day 7, and Day 9
Assessed using the 21-item Depression Anxiety Stress Scales (DASS-21). The instrument consists of three 7-item subscales measuring depression, anxiety, and stress. Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"). Sum scores for each subscale are calculated and multiplied by 2 to yield total scores ranging from 0 to 42 for each dimension (Depression: 0-42, Anxiety: 0-42, Stress: 0-42), with a total overall score ranging from 0 to 126. Higher scores indicate greater levels of psychological distress/severity.
Day 0, Day 7, and Day 9
Psychological measurement: Pain Catastrophizing Scale (PCS)
Tidsram: Day 0, Day 7, and Day 9
Assessed using the 13-item Pain Catastrophizing Scale (PCS) to evaluate catastrophic thoughts and feelings associated with pain (comprising rumination, magnification, and helplessness subscales). Each item is rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time"). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.
Day 0, Day 7, and Day 9
Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
Tidsram: Day 0, Day 7, and Day 9
Assessed using the 9-item short form of the Fear of Pain Questionnaire (FPQ-9) to assess fear of different painful experiences across severe pain, minor pain, and medical pain domains. Each item is rated on a 5-point Likert scale from 1 ("not at all") to 5 ("extreme"). The total score ranges from 9 to 45, with higher scores indicating greater fear of pain.
Day 0, Day 7, and Day 9
Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
Tidsram: Day 0, Day 7, and Day 9
Assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11) to evaluate fear of movement or (re)injury. Each item is scored on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score ranges from 11 to 44, with higher scores indicating greater fear of movement/kinesiophobia.
Day 0, Day 7, and Day 9
Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Tidsram: Day 0 and Day 7
Assessed using the 7-item International Physical Activity Questionnaire - Short Form (IPAQ-SF). The questionnaire measures the duration (minutes) and frequency (days) of walking, moderate-intensity activities, and vigorous-intensity activities performed over the last 7 days. Total physical activity volume is calculated as MET-minutes per week (MET-min/week) using standardised MET energy expenditure values: Walking = 3.3 METs, Moderate PA = 4.0 METs, and Vigorous PA = 8.0 METs. Total score is the sum of (METs × minutes × days) across all three domains, starting at 0 with no strict upper limit. Higher scores indicate higher levels of overall physical activity.
Day 0 and Day 7

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hong Kong Polytechnic University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 augusti 2026

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 augusti 2027

Studieregistreringsdatum

Först inskickad

14 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

17 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pain-Sleep-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera