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

14 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

80

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy Adult with or without insomnia

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Insomnia
Otro: Eccentric exercise
Eccentric hamstring exercise
Healthy contry
Otro: Eccentric exercise
Eccentric hamstring exercise

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep diary: Total Sleep Time
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle damage severity: Muscle pain
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The Hong Kong Polytechnic University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de agosto de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

17 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pain-Sleep-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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