ClinicalTrials.gg
RecruitingNCT07826650Updated Sep 25, 2026

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

An observational study in Insomnia, Healthy Adult and Sleep, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by The Hong Kong Polytechnic University · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University — 8 open to participants now, 8 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · The Hong Kong Polytechnic University.

Started
2026
with 7 others
Observational
3 of 22
3 open now
Registered
21st of 22
by date

Among the 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University, this one is one of 8 that started in 2026, is one of 3 observational ones, and was the 21st registered.

Sleep Initiation and Maintenance Disorders

2,728 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Open to participants now

8 of the 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University are open now, in 2 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Insomnia
  • Healthy Adult
  • Sleep
  • Musculoskeletal Pain

Keywords

  • Insomnia
  • Healthy control
  • Sleep quality
  • Sleep duration
  • Exercise-induced muscle soreness
  • Eccentric exercise
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Adult with or without insomnia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • to vigorous exercise identified through the physical activity readiness questionnaire (PAR-Q)
  • Work night shifts or rotating shift schedules
  • Pregnant
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Insomnia

    Other: Eccentric exercise

  • Healthy contry

    Other: Eccentric exercise

Interventions

  • OtherEccentric exercise

    Eccentric exercise

06

What researchers measure

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 14

  2. 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 14

  3. 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 14

  4. 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 14

  5. 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.

    Time frame: Day 0 to Day 14

  6. 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.

    Time frame: Day 0 to Day 14

  7. 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.

    Time frame: Day 0 to Day 14

  8. 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.

    Time frame: Day 0 to Day 14

Secondary 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 14

  2. 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 14

  3. 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 7

  4. 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 7

  5. 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.

    Time frame: Day 0, Day 7, and Day 9

  6. 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.

    Time frame: Day 0, Day 7, and Day 9

  7. 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.

    Time frame: Day 0, Day 7, and Day 9

  8. 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.

    Time frame: Day 0, Day 7, and Day 9

  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.

    Time frame: Day 0 and Day 7

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

Of 127 non-industry observational studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's planned 12 months is below that.

Counting every sponsor, half of 137 studies reached it within 18 months; a quarter within 4 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 17, 2026
StartActual
Aug 26, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description and arm descriptions
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 2 other changes: description and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07826650
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Aug 26, 2026
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Leo Guohui Lin
Contact
guohui-leo.lin@connect.polyu.hk
+852 94267004

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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