The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls
2026年9月14日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
80
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Leo Guohui Lin
- 電話番号：+852 94267004
- メール：guohui-leo.lin@connect.polyu.hk
研究場所
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Hong Kong、香港
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Leo Guohui Lin
- 電話番号：+852 94267004
- メール：guohui-leo.lin@connect.polyu.hk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Healthy Adult with or without insomnia
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Insomnia
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Eccentric hamstring exercise
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Healthy contry
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Eccentric hamstring exercise
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep diary: Total Sleep Time
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Sleep diary: Sleep Onset Latency (SOL)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Sleep diary: Wake After Sleep Onset (WASO)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Sleep diary: Sleep Efficiency (SE)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Actigraphy: Total Sleep Time (TST)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Actigraphy: Sleep Onset Latency (SOL)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Actigraphy: Wake After Sleep Onset (WASO)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Actigraphy: Sleep Efficiency (SE)
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle damage severity: Muscle pain
時間枠：Day 0 to Day 14
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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.
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Day 0 to Day 14
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Muscle damage severity: Muscle soreness
時間枠：Day 0 to Day 14
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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."
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Day 0 to Day 14
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Sleep Questionnaires: the Insomnia Severity Index (ISI)
時間枠：Day 0 and Day 7
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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
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Day 0 and Day 7
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Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
時間枠：Day 0 and Day 7
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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.
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Day 0 and Day 7
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Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
時間枠：Day 0, Day 7, and Day 9
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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.
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Day 0, Day 7, and Day 9
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Psychological measurement: Pain Catastrophizing Scale (PCS)
時間枠：Day 0, Day 7, and Day 9
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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.
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Day 0, Day 7, and Day 9
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Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
時間枠：Day 0, Day 7, and Day 9
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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.
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Day 0, Day 7, and Day 9
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Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
時間枠：Day 0, Day 7, and Day 9
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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.
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Day 0, Day 7, and Day 9
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Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
時間枠：Day 0 and Day 7
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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.
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Day 0 and Day 7
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月26日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年9月14日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pain-Sleep-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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