Improving sleep before knee replacement to reduce post-surgical pain
Sleep TO Prevent Post-surgical Pain
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06976138 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Baltimore, Maryland and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.