Sleep TO Prevent Post-surgical Pain
STOPPP
2 other identifiers
interventional
252
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
June 18, 2025
June 1, 2025
4.1 years
May 8, 2025
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
3 and 6 months post-surgery
Secondary Outcomes (5)
Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity
immediately post surgery, 6 weeks post surgery
Number of participants with Post-surgical opioid use
6-weeks post-surgery, 3 and 6 months post surgery
Insomnia Severity as assessed by the Insomnia Severity Index
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Circadian Rest Activity Rhythm (RAR) assessed by actigraphy
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9)
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Other Outcomes (5)
Post-surgical Physical Functioning as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Functioning
3 and 6 months post-surgery
Wake After Sleep Onset Time (minutes) as assessed by actigraphy
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Total Sleep Time (minutes) as assessed by actigraphy
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
- +2 more other outcomes
Study Arms (3)
Cognitive Behavioral Therapy + Morning Bright Light exposure
EXPERIMENTALCognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Morning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on/off times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure
ACTIVE COMPARATORCognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the 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 The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Sleep / Knee Osteoarthritis Education + Negative Ion exposure
ACTIVE COMPARATORSleep / Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the 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 The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Interventions
This program will focus on changing the participant's sleep patterns, activities, and habits.
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
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
This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
Eligibility Criteria
You may qualify if:
- People with knee osteoarthritis,
- years old and older,
- scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
- have trouble falling or staying asleep
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (2)
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224, United States
Mass General Brigham
Chestnut Hill, Massachusetts, 02467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael T Smith, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Helen Burgess, PhD
University of Michigan
- PRINCIPAL INVESTIGATOR
Robert R Edwards, PhD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Only the interventionist and biostatistician will have access to group assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 16, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The research community will have access to the data when the award ends. De-identified data will be provided after the requesters sign a Letter of Agreement detailing the purpose of the sharing request, information about the requesters and the requesters affiliations, mechanisms by which the data will be kept secure, and access restricted to the study team. The agreements will also state the recipient will not attempt to identify any individual whose data are included and will not share the data with anyone outside of the research team. NACDA make data available via public-use files (which would require agreement to NACDA's Terms of Use) or via restricted-use files (which would require a signed Restricted Data Use Agreement between the requestor's institution and the Johns Hopkins University as well as an application to request access).
- Access Criteria
- Pll data sharing will follow the guidelines and rules of the NIH and Johns Hopkins University's Institutional Review Board (IRB). Deidentified data will be managed as indicated in the informed consent. The Informed Consent will notify participants that the data will be shared. De-identified data will be share to the extent indicated in the informed consent. Final curated, de-identified, anonymized data sets underlying publications resulting from the proposed research involving human subjects will be generated and will be shared only to the extent indicated in the informed consent. Requesters will sign a Letter of Agreement with the Johns Hopkins University detailing the requesters planned uses of the data and mechanisms by which the data will be kept secure, and access restricted to the requesters study team with appropriate credentials and training in data security. NACDA's application for restricted-use data will be followed.
Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the data sets. Study documentation (e.g., study protocols) will be made accessible via clinicaltrials.gov and via communication with the principal investigators to facilitate interpretation of the scientific data. Codebooks, other study documentation and deidentified data will be made available on the National Institute on Aging (NIA) National Archive of Computerized Data on Aging data (NACDA) repository.