Sleep and Pain in Osteoarthritis

NCT07821047 | Not Yet Recruiting

• 1 other identifier: 2026-079-KB
• Study Type: observational
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee; Osteoarthritis (OA) of the Hip

Keywords

sleep; insomnia; osteoarthritis; pain; pain and sleep associations; hip; knee; sleep misperception; objective and subjective sleep

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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)

  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.

  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

  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.

  After recruitment for up to 28 days, each morning for 7 days total.

Secondary Outcomes (17)

• Pain catastrophising

  At recruitment

• Dysfunctional beliefs about sleep

  Up to 28 days after recruitment

• Chronotype

  Up to 28 days after recruitment

• Sleep effort

  At recruitment

• Pre-sleep cognitive and somatic arousal

  After recruitment for up to 28 days. For 7 mornings in total after sleep monitoring.

Other Outcomes (3)

• Demographics

  At recruitment

• Physical activity

  At recruitment

• Health-related Quality of Life

  Up to 28 days after recruitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic outpatients with hip or knee osteoarthritis attending clinic at Hampshire Hospitals NHS Foundation Trust, Basingstoke RG24 9NA, UK

You may qualify if:

• Adults over 18 years with hip or knee osteoarthritis or both, confirmed by clinical staff or self-report plus application of American College of Rheumatology (ACR) clinical criteria for osteoarthritis of the hip or knee at the time of screening.

You may not qualify if:

• Cognitive impairment
• Participants who have already had hip or knee joint replacement surgery
• Cancer which is not in remission
• Other forms of arthritis for example rheumatoid arthritis
• Participants with a nociplastic pain condition, for example fibromyalgia, neuropathic pain, or spinal surgery.
• Sleep-disordered breathing including participants with a known diagnosis of obstructive sleep apnoea, sleepwalking, or nightmare disorder.
• A diagnosis, or symptoms consistent with restless legs syndrome
• Serious medical or mental health conditions which have not been stable on the same medication for the past 3 months for example heart failure, COPD, diabetes, or psychosis.
• Participants who have started a new medication or changed a dose of medication within the past 3 months that could impact pain or sleep for example betablockers or antidepressants.

Sponsors & Collaborators

• University of Reading: lead
• Hampshire Hospitals NHS Foundation Trust: collaborator

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MeSH Terms

Conditions

Osteoarthritis; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katie L Barfoot, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy A Holden, MBBS

CONTACT

+44774813184; w.a.holden@pgr.reading.ac.uk

Katie L Barfoot, PhD

CONTACT

+441183783347; katie.barfoot@reading.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 15, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share