NCT06976138 · Johns Hopkins University
Sleep TO Prevent Post-surgical Pain
(STOPPP)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive-Behavioral Therapy for Insomnia
This program will focus on changing the participant's sleep patterns, activities, and habits.
DEVICE
Bright Light therapy via the Re-Timer®
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer® The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery
DEVICE
Negative Ion exposure via IonMi Device
This procedure involves wearing a light weight negative ionizer (IonMi Device) around neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery
BEHAVIORAL
Sleep / Knee Osteoarthritis Education
This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
Primary outcome measures
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 3 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
- Chestnut Hill, Massachusetts
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations