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Sleep Interventions to Prevent Post-surgical Pain after Knee Replacement

This study is looking at different ways to help people with sleep problems before total knee replacement surgery for knee osteoarthritis. Researchers want to see if combining Cognitive-Behavioral Therapy for Insomnia (talk therapy for sleep problems) with bright light exposure is better at reducing pain after surgery than other approaches. You might be able to join if you are 60 or older, have knee osteoarthritis, are scheduled for one knee replacement surgery, and have trouble falling or staying asleep. The study will measure chronic (long-lasting) pain after surgery at 3 and 6 months to see if these sleep interventions are helpful. The current status of this study is unclear, and it plans to enroll 252 participants.

Study design
This interventional study plans to enroll 252 participants. It compares different behavioral and device-based interventions for sleep problems.
What's involved
You would participate in Cognitive-Behavioral Therapy for Insomnia or education. You might also use a bright light device (Re-Timer®) or a negative ion device (IonMi Device) for one hour each morning for several weeks before and after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for chronic postsurgical pain at 3 and 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06976138

Sleep TO Prevent Post-surgical Pain

Recruiting
NAAges 60+InterventionalTreatment
Johns Hopkins University
~252 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Cognitive-Behavioral Therapy for InsomniaBright Light therapy via the Re-Timer®Negative Ion exposure via IonMi DeviceSleep / Knee Osteoarthritis Education

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Measured over 3 and 6 months post-surgery

Conditions

Knee Osteoarthristis

Explore related trials

Osteoarthritis of knee

NCT06976138

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins School of Medicine

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Mass General Brigham

    Chestnut Hill, Massachusettsno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael T Smith, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
  • Helen Burgess, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Robert R Edwards, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Anna Kim-Dahl
[email protected]
410-550-5704
Email the study team

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Eligibility criteria

Inclusion

People with knee osteoarthritis,
60 years old and older,
scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
have trouble falling or staying asleep

Exclusion

currently using medications to help sleep
have completed Cognitive Behavioral Therapy for Insomnia
used either Bright Light or Negative Ion exposures in the past year
have an inflammatory rheumatologic disorder, seizure disorder
serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
serious sleep or circadian rhythm disorder, untreated sleep apnea
are pregnant or lactating
have retinal pathology
history of eye surgery (Lasik or cataract okay if more than 3 months ago)
are taking disease-modifying antirheumatic drugs
taking photosensitizing medications
are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling

What this trial measures

  • Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index3 and 6 months post-surgery

    Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.