InsomniaNCT07826650
The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls
An observational study of Insomnia and Healthy Adult, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Healthy Adult, Sleep
- What is being tested?
- Eccentric exercise
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Aug 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Adult with or without insomnia
Who may be able to join
- Adults aged 18 to 60 years
- Right-hand and right-foot dominant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
the Hong Kong Polytechnic University
Hong Kong
Leo Guohui Lin, +852 94267004, guohui-leo.lin@connect.polyu.hk
About this study
Official title: 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 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, Sleep, Musculoskeletal Pain
- Being tested
- Eccentric exercise
- Keywords
- Insomnia, Healthy control, Sleep quality, Sleep duration, Exercise-induced muscle soreness, Eccentric exercise
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseOther
Eccentric exercise
| Study group | Role | What they receive |
|---|---|---|
| Insomnia | Not described Receives: Other: Eccentric exercise | |
| Healthy contry | Not described Receives: Other: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 to Day 14
Secondary outcomes (9)
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.
Measured: Day 0 to Day 14
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."
Measured: Day 0 to Day 14
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
Measured: Day 0 and Day 7
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.
Measured: Day 0 and Day 7
Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Day 0, Day 7, and Day 9
Psychological measurement: Pain Catastrophizing Scale (PCS)
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.
Measured: Day 0, Day 7, and Day 9
Psychological measurement: Fear of Pain Questionnaire (FPQ-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.
Measured: Day 0, Day 7, and Day 9
Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
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.
Measured: Day 0, Day 7, and Day 9
Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
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.
Measured: Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start26 Aug 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826650
- Sponsor's protocol ID
- Pain-Sleep-2026
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls: a Case-control Study
- ClinicalTrials.gov ID
- NCT07826650
- Acronym / sponsor ID
- Pain-Sleep-2026
- Conditions
- Insomnia, Healthy Adult, Sleep, Musculoskeletal Pain
- Keywords
- Insomnia, Healthy control, Sleep quality, Sleep duration, Exercise-induced muscle soreness, Eccentric exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia | – | Other: Eccentric exercise |
| Healthy contry | – | Other: Eccentric exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Adult with or without insomnia
Key inclusion criteria (2 listed)
- Adults aged 18 to 60 years
- Right-hand and right-foot dominant
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exerciseEccentric exercise | Other | Healthy contry, Insomnia |
Primary outcome
Sleep diary: Total Sleep Time
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Muscle damage severity: Muscle pain
Time frame: Day 0 to Day 14
Muscle damage severity: Muscle soreness
Time frame: Day 0 to Day 14
Sleep Questionnaires: the Insomnia Severity Index (ISI)
Time frame: Day 0 and Day 7
Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 0 and Day 7
Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Day 0, Day 7, and Day 9
Psychological measurement: Pain Catastrophizing Scale (PCS)
Time frame: Day 0, Day 7, and Day 9
Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
Time frame: Day 0, Day 7, and Day 9
Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Day 0, Day 7, and Day 9
Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: Day 0 and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Healthy Adult, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leo Guohui Lin (+852 94267004, guohui-leo.lin@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary: Total Sleep Time (time frame: Day 0 to Day 14). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.