Status:
RECRUITING
Sleep TO Prevent Post-surgical Pain
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Knee Osteoarthristis
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure...
Detailed Description
This research is being done to evaluate whether combining Cognitive Behavioral Therapy for Insomnia (talk therapy for insomnia) with Morning Bright Light exposure is more effective than Morning Negati...
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
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06976138
Start Date
June 13 2025
End Date
July 31 2029
Last Update
June 18 2025
Active Locations (2)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224
2
Mass General Brigham
Chestnut Hill, Massachusetts, United States, 02467