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Can better sleep ease knee pain? new study tests sleep therapy for osteoarthritis

NCT ID NCT05387473

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study looks at whether adding cognitive behavioral therapy for insomnia (CBT-I) to standard knee osteoarthritis care (education and exercise) helps reduce pain and improve function. About 128 adults aged 45+ with both knee osteoarthritis and insomnia will be followed for 6 months. The goal is to see if treating sleep problems leads to better outcomes than standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy for insomnia (CBT-I) combined with exercise therapy and education
What this could lead to
If it works, this could offer a better way to manage knee osteoarthritis pain by treating insomnia alongside standard care.
What could go wrong
This is a relatively small, early-stage study (128 participants) and the added benefit of CBT-I may be modest. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 45 years old or older Being a fluent Dutch speaker Commits to study requirements Knee Osteoarthritis classified using the American college of Rheumatology criteria (Knee pain + 3/6 for diagnosis): * age\>50 * morning stiffness \<30 minutes * crepitus * bony tenderness * bony enlargement * no palpable warmth Insomnia diagnosis using the DSM-5 criteria: * No shiftwork * No severe untreated sleep disorders * For at least \>3 days / week for \>3 months: \>30 minutes sleep latency and/or \>30 minutes awake after sleep onset and/or early-morning awakening with inability to return to sleep AND associated daytime symptoms Knee pain nominated by the patient as 3 or higher on a visual analogue scale on most days of the last 3 months Informed consent Exclusion Criteria: Treatment with supervised exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) or CBT-I in the preceding six months Change in any psychiatric or psychological treatment the last 3m or planned during the study period Concurrent intense psychological treatment (weekly basis) BMI \>30 Mini-Mental state examination score of 23 or lower Being on the waiting list for a knee replacement or having received knee replacement on symptomatic side Any contra-indication for exercise therapy Existing diagnose that has impact on sleep and patients are therefore unlikely to respond to CBT-I: any rheumatological condition (e.g. rheumatoid arthritis, Lupus, Sjogren's syndrome); any neurological conditions (e.g. stroke, Multiple sclerosis, Parkinson's disease), dementia or receiving cholinesterase inhibitors; cancer diagnosis in the past year and receiving chemotherapy or radiation therapy in the past year; Long-COVID or inpatient treatment for congestive heart failure within the prior six months. Having severe underlying sleep disorder (obstructive sleep apnea over AHI \>15, periodic leg movement disorder, restless leg syndrome, sleep-wake cycle disturbance, rapid eye movement behavior disorder) Being pregnant or given birth in the preceding year Having an external/ physical factor that limits the opportunity to sleep (E.g. newborn)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department Rehabilitation Science

    Leuven, Leuven, 3000, Belgium

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