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Clinical trial Recruiting at 1 site Interventional Ages 60 and up

Improving sleep before knee replacement to reduce post-surgical pain

Official title: Sleep TO Prevent Post-surgical Pain

Run by Johns Hopkins University · NCT06976138 · Data updated 2026-11-12

This study will see if adding cognitive behavioral therapy for insomnia plus morning bright light is better than negative ion exposure with either CBT-I or sleep/knee education at reducing pain after total knee replacement in people 60+ with knee osteoarthritis who have trouble sleeping.

Quick facts

Study typeInterventional
Ages60 Years and up
SexAll
Enrollment252 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations2 sites (Baltimore, Maryland and 1 other locations)
StatusRecruiting
StartedJune 13, 2025
Main results expectedJuly 31, 2029
Study endsJuly 31, 2029
Registry record updatedAugust 7, 2026
Trial IDNCT06976138 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people aged 60 or older with knee osteoarthritis who are scheduled for a unilateral total knee replacement and report difficulty falling or staying asleep, and who meet the study's medical and medication eligibility rules.

Probably not a fit

Patients currently using prescription sleep medications, who have completed CBT-I, have recent bright light/negative ion use, uncontrolled sleep disorders like untreated sleep apnea, certain neurologic or severe psychiatric conditions, active inflammatory rheumatologic disease, retinal pathology, or other listed exclusions are unlikely to qualify or benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Older adults (60+) with knee osteoarthritis who are scheduled for a unilateral total knee replacement and have trouble falling or staying asleep are enrolled and randomized to different pre-surgical sleep interventions. Interventions include Cognitive Behavioral Therapy for Insomnia (CBT-I), morning bright light delivered with a wearable Re-Timer® device, a wearable negative ionizer (IonMi), or sleep/knee osteoarthritis education, delivered before surgery. The study compares combinations of these approaches to measure effects on post-operative pain and recovery using standardized pain and function assessments after surgery. Wearable devices meet safety standards and participants must meet specific medical and medication-related eligibility criteria.

Why it matters

Potential benefit: If successful, treating sleep problems before surgery could lower pain after knee replacement and improve recovery and function.

How similar studies have gone: CBT-I is well established to improve insomnia and has shown some links to reduced pain, bright light therapy has mixed evidence for sleep timing and mood, while negative ion exposure is less well established and more novel in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Johns Hopkins School of Medicine
    Baltimore, Maryland, United States     Recruiting
  • Mass General Brigham
    Chestnut Hill, Massachusetts, United States     Active not recruiting

Study contacts

  • Principal investigator: Michael T Smith, PhD — Johns Hopkins University
  • Study coordinator: Anna Kim-Dahl
  • Email: akimdah1@jhu.edu
  • Phone: 410-550-5704

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Knee Osteoarthristis 30Johns Hopkins University 3238
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.