An observational study in Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, sponsored by University of Reading. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Reading · Observational
People with osteoarthritis and painful joints often report poor sleep, but poor sleep can also increase pain. There have been very few studies of sleep in osteoarthritis using physical measuring devices, but in other painful conditions many people report worse sleep in questionnaires than actual sleep measured using wristwatch devices called actigraphs. This is called sleep misperception. Sleep misperception may affect the amount of pain that people report. Sleep misperception could be influenced by negative factors such as pain catastrophising (a tendency to ruminate on pain and its consequences), but also positive factors such as resilience and optimism. People who do not sleep well also have increased levels of "inflammation" in their blood (C-Reactive Protein, or CRP) and reduced pain thresholds for example to pressure or heat when tested in the laboratory. The aims of this study are to compare questionnaire and actigraphy measures of sleep in people with hip and knee osteoarthritis to see if there is sleep misperception. It is anticipated that people who report worse subjective compared to objective sleep will report more pain and have higher pain catastrophising as well as lower pain thresholds and less positive personality characteristics such as resilience. Participants will be asked to complete questionnaires about pain and sleep, mood and resilience, and to wear a wrist sleep monitoring device continuously for 7 days and nights and a brief daily sleep, pain and mood questionnaire. Willing participants will be asked to provide a pinprick of blood to measure CRP (inflammation), and Quantitative Sensory Testing (QST) for pressure pain and thermal pain thresholds using a blunt nylon filament and a heat probe on one forearm. Information from this study will be used to inform the development of a psychological intervention designed to improve resilience, sleep reporting and potentially pain.
Osteoarthritis is the most common type of arthritis, most often affecting the hips and knees. Apart from pain and disability, many people with osteoarthritis anecdotally report sleep disturbances. The prevalence of self-reported sleep problems in osteoarthritis varies widely ranging from 11.9% (Gore et al., 2011) to 81% (Wilcox et al., 2000), however, these figures have not been supported by studies using objective sleep measures. While the relationship between sleep and pain is bidirectional (Frohnhofen, 2018), there is increasing evidence that sleep disturbance may impact pain, more than pain impacts sleep (Finan et al., 2013). In addition, patients with hip osteoarthritis believe that if they have better subjective sleep, their pain will improve (Blagestad et al., 2016). Sleep quality before hip and knee joint replacement is also one of the most crucial factors determining both immediate and longer-term post-operative pain (Bjurström et al., 2021; Boye Larsen et al., 2021).
There are theoretical reasons to explain why poor sleep could affect pain in osteoarthritis. Fragmented sleep may activate immune and inflammatory pathways which can increase central pain processing, as well as via an effect on mood (Smith et al., 2009). Meta-analyses have shown that sleep deprivation increases pain sensitivity in healthy controls (Schrimpf et al., 2015), and both short sleep duration and insomnia are causally linked to the development of chronic widespread pain (Williams et al., 2024). In osteoarthritis, participants with both pain and insomnia have increased central sensitisation on Quantitative Sensory Testing compared to controls (Campbell et al., 2015). Emerging evidence suggests that chronotype, an individual preference for "morningness" or "eveningness" may influence sleep quality, with "morning" types reporting better sleep quality (Yazdi et al., 2014). In addition, "evening" types may be more susceptible to musculoskeletal pain (Zhang et al., 2018), although the mechanisms for this are unclear. Qualitatively, patients with osteoarthritis describe difficulty getting to sleep, due to pain and positioning problems, as well as frequent waking during the night and difficulty getting back to sleep (Whale \& Rachael, 2022). Self-reports of poor sleep in osteoarthritis are also associated with an increased level of pain catastrophizing (Campbell et al., 2015), a tendency to constantly think about pain and the negative consequences of pain (Quartana et al., 2009). A meta-analysis of plasma C-Reactive Protein (CRP) levels, a protein produced by the liver in response to the presence of inflammatory cytokines that is involved in immune activation and a biomarker for a peripheral inflammatory state, has shown a modest but significant increase in people with osteoarthritis (Jin et al., 2015). Experimental sleep deprivation is associated with higher levels of plasma CRP (Irwin et al., 2016) and cross-sectional population studies show that both shorter and longer than average sleep duration is associated with higher levels of plasma CRP (Lee et al., 2020; Zhang et al., 2023).
Potentially, as objective sleep data is time consuming and expensive to collect, most sleep studies in osteoarthritis favour subjective, self-report measures of sleep quality, such as the Pittsburgh Sleep Quality Index (PSQI) 1989) and the Insomnia Severity Index (ISI). Quantitative objective measurements, such as actigraphy or polysomnography (PSG) are much less commonly used and are typically used for only a few days. In two of the very few PSG studies of sleep in osteoarthritis, one showed more sleep-stage transitions suggestive of sleep fragmentation in people with osteoarthritis compared to controls (Yeung et al., 2018), another showed more light than deep sleep, implying worse sleep quality in people with osteoarthritis compared to controls (Leigh et al., 1988), although this study is limited by a sole recruitment of male participants. Whether this would replicate in a mixed sample remains an empirical question. In many sleep studies, it is common to find a disparity between subjective and objective measures of sleep quality, in particular, worse self-reported sleep efficiency and total sleep time, compared to objective sleep measures (Bean et al., 2021; Heitkemper et al., 2005). This phenomenon is often called 'sleep misperception' (Hughes et al., 2018).
The extent of sleep misperception varies between different clinical populations and in one study, increasing pain levels, but not age, depression or dysfunctional sleep beliefs lead to the greatest difference between subjective and objective sleep measures, suggesting that pain can cause people to negatively interpret their sleep (Hughes et al., 2018). Sleep misperception has been reported in people with several different pain conditions including rheumatoid arthritis (Hirsch et al., 1994) but not so far in osteoarthritis. Due to a paucity of empirical literature, the mechanisms underlying sleep misperception are unclear. One theory is that people who underestimate their sleep may have more frequent brief nocturnal awakenings (Harvey \& Tang, 2012), also suggested in a small objective study in osteoarthritis (Yeung et al., 2018).
Positive personality factors that may be protective of sleep or sleep misperception such as resilience or self-efficacy have not been widely studied. Resilience has been described as an important characteristic that can help individuals "bounce-back" from challenging situations allowing adaptation and personal growth and is considered important regarding outcomes related to chronic pain (Smith \& Zautra, 2008). Sleep and resilience are positively correlated in healthy individuals (Arora et al., 2022) and people with knee osteoarthritis who have high levels of psychological resilience also have higher levels of self-rated health (Hsieh et al., 2023). Three personal characteristics have been considered key characteristics of increased pain resilience - optimism, pain acceptance, and purpose in life (Smith \& Zautra, 2008). In addition, self-efficacy (Bandura, 1977) which in the context of health is a belief in one's abilities to control symptoms, as well as external factors such as emotional or social support are also likely influence recovery or "bounce-back" from setbacks. Optimists tend to report better subjective sleep (Lau et al., 2017), lower levels of clinical pain (Shanahan et al., 2021) and lower pain catastrophising scores (Hood et al., 2012). In osteoarthritis, optimism is associated with less clinical pain and less experimental pain sensitivity (Thompson et al., 2018). In addition, people with more optimistic traits tend to report better sleep quality and fewer insomnia symptoms than those with fewer optimistic traits, even if their objective sleep is impaired, demonstrating a favourable sleep misperception pattern (Hernandez et al., 2020). This suggests that optimism may be a protective factor against the negative impact of sleep misperception and subsequent pain. The broader concept of pain resilience related to sleep has yet to be investigated in clinical populations with osteoarthritis. Another factor that may contribute to sleep misperception in osteoarthritis could be pain catastrophising; a collection of negative cognitive and affective biases to pain associated with feelings of helplessness (Quartana et al., 2009). In people with osteoarthritis, sleep disturbance is associated with both pain catastrophising and the level of knee pain (Wang et al., 2023).
A systematic review looking at sleep and pain associations in osteoarthritis is currently being undertaken within the lead authors lab (Holden et al, in prep). 25 publications with a total of 13,841 participants with OA were included. The prevalence of self-reported poor sleep ranged from 25% (Gore et al., 2011) to 81.1% (Wilcox et al., 2000). Importantly, the extent to which conclusions can be drawn from the data are limited by the high heterogeneity across studies, as well as methodological limitations, including the variability in diagnostic criteria for osteoarthritis, low statistical power in objective measurement and a lack of consideration for known sleep confounders. Across the 25 included studies, 11 different subjective sleep outcome measures and 12 different pain measures were used. Objective sleep monitoring was used in only 5 studies, and of these only 2 actigraphy studies were used for 7 nights which is the generally agreed minimum number of nights needed to accurately assess sleep. 2 studies examined the effects of poor sleep on next day pain. One found an association between poor self-reported sleep, but not sleep recorded by actigraphy, and morning pain (Whibley et al., 2019). The other found no association between sleep measured by actigraphy and next day pain or vice versa (Parmelee et al., 2017). There were only 3 longitudinal studies, both of which used non-standardised methods for quantifying sleep quality. One found that more nights of restless sleep per week was associated with increased pain at baseline but not at 1 year (Lapane et al., 2021) and the other found that reports of poor sleep were also associated with baseline pain but not at 4-year follow-up (Parmelee \& Tighe, 2015). Only 2 studies considered both subjective and objective measures of sleep (Campbell et al., 2015) (Chen et al., 2015), with only one being sufficiently powered to detect an effect (Campbell et al., 2015). In this study, counterintuitively, people with osteoarthritis and insomnia had better subjective compared to objective sleep than control groups. Most cross-sectional studies reported an association between either worse sleep quality or quantity and increased pain or vice-versa, however the strengths of these associations were often weak. No studies in the systematic review considered personality factors that could have been protective of sleep.
In summary, poor sleep and pain are associated in people with osteoarthritis; however, the nature and strength of this association is unclear from the available literature. This study aims to clarify the nature and extent of sleep problems in people with clinically diagnosed hip or knee osteoarthritis using objective as well as subjective sleep measures, and to identify any sleep misperception. In addition, this study aims to clarify any association between sleep misperception and subjective pain reports and to identify factors including pain catastrophising and resilience which might mediate this association. The aim is to identify personality factors which could be amenable to a brief psychological intervention, for example mindfulness, that could influence sleep misperception and pain reporting. Measures of peripheral inflammation and central sensitisation, both theorised as mechanisms linking sleep quality and pain will be measured using plasma CRP and with Quantitative Sensory Testing.
Research Questions
The principal research question is as follows:
Is there an association between sleep misperception and pain in hip and knee osteoarthritis?
The secondary research questions are as follows:
Is negative sleep misperception associated with pain catastrophising?
Is there less sleep misperception in participants with positive personality attributes such as resilience and optimism?
Which sleep variables predict the presence/absence of sleep misperception
Is sleep misperception in osteoarthritis associated with raised levels of plasma CRP, a marker of general inflammation?
Is sleep misperception in osteoarthritis associated with central sensitisation measured with Von Frey Filaments and a thermal cutaneous stimulator?
Enrolment and Procedures Adults over 18 years old with hip and knee osteoarthritis will be recruited from NHS orthopaedic clinics at Hampshire Hospitals NHS Foundation Trust, Basingstoke. After screening for inclusion and exclusion criteria, participants will complete a consent form either on paper or via REDCap electronically. They will then complete a battery of psychometrics to quantify aspects of their personality, pain and sleep as well as their demographics. Participants will then also be asked to wear a wrist actigraphy monitor continuously for 7 days and nights to objectively measure their objective sleep quality and quantity. Additionally, each morning after sleep monitoring, participants will complete a brief sleep diary, a pain numerical rating scale and a visual analogue mood scale to assess subjective sleep quantity and quality, pain and mood over the trial period. Willing participants will also be asked to provide a blood sample of approximately 100 microlitres, via a home testing kit, collected into a capillary tube from a pinprick of blood to quantify high sensitivity C-Reactive Protein. At the conclusion of the week-long monitoring period, participants will complete several more sleep and pain questionnaires. Optional Quantitative Sensory Testing (QST) using standardised protocols will also be performed in the participants homes using Von Frey Filaments to assess pressure pain threshold and a thermal cutaneous stimulator to assess thermal pain threshold. Feedback on sleep results will be provided to each participant by telephone or videocall.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 73 is below the median of 100 across 601 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Orthopaedic outpatients with hip or knee osteoarthritis attending clinic at Hampshire Hospitals NHS Foundation Trust, Basingstoke RG24 9NA, UK
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.
Exclusion Criteria:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perceived sleep quality
This will be measures using The Pittsburgh Sleep Quality Index (PSQI) which records perceived sleep quality over the past 4 weeks using 19 items recorded on a 4-point scale. Increasing scores indicate worsening sleep quality.
Time frame: At recruitment
Severity of insomnia symptoms
The Insomnia Severity Index (ISI) will be used to record the the severity of insomnia symptoms and the consequences of sleep problems over the past 2 weeks. This is a 7-item questionnaire rated on a 5-point scale with higher scores indicating increasing severity of insomnia symptoms.
Time frame: At recruitment
Sleep duration (perceived)
Each morning for 7 mornings, participants will complete the Consensus AM sleep diary detailing their perceived sleep time in minutes. This number will be calculated by subtracting the time they woke up from the time they estimate that they went to sleep the night before.
Time frame: From the date of recruitment for up to 28 days after recruitment
Sleep duration (actigraphic)
Objective sleep duration in minutes will be recorded with a CamNTech MotionWatch 8 for 7 nights.
Time frame: From the date of recruitment for up to 28 days.
Sleep misperception (sleep duration)
Sleep misperception will be quantified in terms of the difference between objective (actigraphic) and subjective (diary) sleep time in minutes. Sleep misperception will be correlated with the level of pain (WOMAC and daily VAS)
Time frame: From recruitment for up to 28 days.
Sleep misperception (sleep efficiency)
Sleep efficiency, expressed as a percentage will be calculated as the difference between perceived time in bed and time asleep in minutes as recorded by daily Consensus sleep diary, and Actigraphy.
Time frame: Between recruitment and up to 28 days for 7 mornings in total.
Osteoarthritis pain over the past month
A clinical measure of osteoarthritis pain over the past month will be recorded using the pain scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for osteoarthritis of the hip or knee, a 5-item questionnaire scored on a 4-point Likert scale. This will be correlated with the degree of sleep misperception
Time frame: At recruitment
Osteoarthritis daily pain
Daily pain will be measured using an 11-point numeric rating scale (NRS) Higher scores on these questionnaires mean higher levels of pain. Pain on an 11 point numerical rating scale. This will be correlated with the degree of sleep misperception.
Time frame: After recruitment for up to 28 days, each morning for 7 days total.
Pain catastrophising
Pain catastrophising will be measured using the Pain Catastrophising Scale (PCS), a 13-item questionnaire with each item rated on a 5-point scale where higher values indicate higher levels of pain catastrophising. Pain catastrophising will be correlated with the level of pain and sleep misperception.
Time frame: At recruitment
Dysfunctional beliefs about sleep
Dysfunctional Beliefs About Sleep will be measured with the 16-item Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS-16) rated on an 11-point numerical rating scale with higher scores indicating higher dysfunctional beliefs about sleep.
Time frame: Up to 28 days after recruitment
Chronotype
Chronotype will be measured by the Reduced Morningness-Eveningness Questionnaire (rMEQ) a 5-item scale measured on a 4-point scale with higher scores indicating a greater preference for "morningness".
Time frame: Up to 28 days after recruitment
Sleep effort
Sleep Effort will be measured using the Glasgow Sleep Effort Scale, a 7-item questionnaire with 3 possible responses for each item according to the level of agreement regarding sleep effort, with higher scores indicating greater sleep preoccupation or worry about sleep and the amount of effort put into sleeping.
Time frame: At recruitment
Pre-sleep cognitive and somatic arousal
Pre-sleep cognitive arousal and somatic arousal will be assessed with the following 2 questions based on Tang et al 2012 "As you were trying to go to sleep last night, did thoughts keep running through your mind?"; 0-10 NRS: 0 "not at all," 10 "very much so" and ("As you were trying to go to sleep last night, did you experience a jittery, nervous feeling in your body?"; 0-10 NRS: 0 "not at all," 10 "very much so").
Time frame: After recruitment for up to 28 days. For 7 mornings in total after sleep monitoring.
Daily mood
A 6-item Visual Analogue Scale for Mood (VASM) with the ends labelled "not at all" and "extremely" happy, sad, calm, tense, energetic, and sleepy will be used to assess daily mood during the monitoring period. General Anxiety Disorder-7 (GAD-7) will be used to assess symptoms of anxiety. Mood symptoms will be correlated with pain and sleep misperception
Time frame: Between recruitment for up to 28 days, every morning after sleep monitoring for 7 mornings.
Positive and negative emotions
The Positive and Negative Affect Schedule (PANAS) will be used to measure the balance of positive and negative emotions over the past month
Time frame: At recruitment
Symptoms of depression
The Patient Health Questionnaire-8 (PHQ-8) will be used to assess symptoms of depression
Time frame: At recruitment
Symptoms of anxiety
Anxiety symptoms will be measures using the General Anxiety Disorder-7 questionnaire (GAD-7)
Time frame: At recruitment
Arthritis self-efficacy
Arthritis self-efficacy will be measured using the 8-item Arthritis Self-Efficacy Questionnaire, an 8-item scale using a 10-point VAS with higher scores indicating higher self-efficacy.
Time frame: At recruitment
Pain acceptance
Pain acceptance will be measured using the Chronic Pain Acceptance Questionnaire-8.
Time frame: At recruitment
Pain resilience
Pain resilience will be measured using the 14-item Pain Resilience Scale using a 5-point Likert scale reflecting behavioural perseverance and cognitive/affective positivity.
Time frame: At recruitment
Optimism
Optimism will be measured using the 10-item Life Orientation Test-Revised (LOT-R), using a 5-point Likert Scale.
Time frame: At recruitment
Meaning in life
Purpose in life will be assessed using the 10-item Meaning in Life questionnaire (MIL) on an 8-point Likert scale reflecting purpose/meaning in life.
Time frame: At recruitment
Emotional support
Emotional support will be measured using the Short Form 6a of the Patient-Reported Outcomes Measurement Information System Emotional Support questionnaire using a 6-item Likert scale reflecting the level of social support
Time frame: At recruitment
Quantitative sensory testing
Pain thresholds will be measured using quantitative sensory testing (QST). This is a form of sensory testing that uses equipment to provide a mildly painful stimulus and asking participants to provide verbal reports to calculate their pain threshold. Pressure pain thresholds will be quantified via the use of a nylon 'Von Frey Filament'. This is a small blunt nylon fibre, 0.8mm in diameter. When pressed down onto the thenar eminence (base of the thumb) a specific amount of force is applied. This means the stimulus is consistent for every participant. Participants will be asked to provide a rating between 0-10 to indicate the perceived pain intensity. Thermal pain threshold and a measure of temporal summation as an indicator of central sensitisation will be recorded using a Thermal Cutaneous Stimulator (QST-Lab TS2). QST measures will be correlated with sleep misperception and pain.
Time frame: Up to 28 days after recruitment
Plasma high sensitivity CRP
Plasma high sensitivity CRP will be measured using a finger prick sample of blood, approximately 50 microlitres, in a capillary tube using a standardised kit, supplied and analysed by the manufacturers using Enzyme-Linked Immunosorbent assay (ELISA), (Thriva-x, Thriva Limited, London, UK). Plasma CRP level will be correlated with pain and degree of sleep misperception.
Time frame: Up to 28 days after recruitment
Demographics
Information regarding demographics will include site of osteoarthritis, age, sex, years of education, work including shift pattern, menopausal status, body mass index (BMI) by self-report, ethnicity, comorbidities including anxiety or depression, medication including supplements and HRT, smoking, caffeine and alcohol.
Time frame: At recruitment
Physical activity
A brief estimate of level of physical activity will be measured using the General Practice Physical Activity Questionnaire (GPPAQ)
Time frame: At recruitment
Health-related Quality of Life
This will be measured with the EuroQol 5-D (ED-5D-5L)
Time frame: Up to 28 days after recruitment
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD that underlie results in a publication.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.