Status:
ACTIVE_NOT_RECRUITING
Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Conditions:
Osteoarthritis, Knee
Insomnia
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Knee osteoarthritis (KOA) is the leading and fastest increasing cause of disability in older adults. It is a serious health issue related with a high health care utilisation. The first-line KOA manage...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05387473
Start Date
May 25 2022
End Date
November 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
Department Rehabilitation Science
Leuven, Leuven, Belgium, 3000