Sleep TO Prevent Post-surgical Pain
Recruiting · NCT06976138 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Bright Light therapy via the Re-Timer®Cognitive-Behavioral Therapy for InsomniaNegative Ion exposure via IonMi DeviceSleep / Knee Osteoarthritis Education
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 2 US states.
- Johns Hopkins School of Medicine - Baltimore, Maryland, United States
- Mass General Brigham - Chestnut Hill, Massachusetts, United States