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

NCT07826650 | Recruiting

• 1 other identifier: Pain-Sleep-2026
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Healthy Adult; Musculoskeletal Pain; Sleep

Keywords

Insomnia; Healthy control; Sleep quality; Sleep duration; Exercise-induced muscle soreness; Eccentric exercise

Outcome Measures

Primary Outcomes (8)

• 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.

  Day 0 to Day 14

• 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.

  Day 0 to Day 14

• 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.

  Day 0 to Day 14

• 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.

  Day 0 to Day 14

• Actigraphy: Total Sleep Time (TST)

  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)

  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)

  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)

  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

Secondary Outcomes (9)

• 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

Study Arms (2)

Insomnia

Other: Eccentric exercise

Healthy contry

Other: Eccentric exercise

Interventions

Eccentric exercise OTHER

Eccentric exercise

Healthy contry; Insomnia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adult with or without insomnia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

the Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leo Guohui Lin

CONTACT

+852 94267004; guohui-leo.lin@connect.polyu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 17, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)