Sleep TO Prevent Post-surgical Pain

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06976138
Status
Recruiting
Apply to this trial

Conditions

  • Knee Osteoarthristis

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive-Behavioral Therapy for Insomnia — BEHAVIORAL
    This program will focus on changing the participant's sleep patterns, activities, and habits.
  • Bright Light therapy via the Re-Timer® — DEVICE
    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
  • Negative Ion exposure via IonMi Device — 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
  • Sleep / Knee Osteoarthritis Education — BEHAVIORAL
    This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Behavioral Therapy + Morning Bright Light exposure
    Cognitive-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.
  • Active Comparator: Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure
    Cognitive-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.
  • Active Comparator: Sleep / Knee Osteoarthritis Education + Negative Ion exposure
    Sleep / 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.

Primary Outcome Measure

Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 3 and 6 months post-surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21224
Anna Kim-Dahl
[email protected]
410-550-5704
Heavon Allen
[email protected]
4105501000
Michael T Smith, PhD (PRINCIPAL_INVESTIGATOR)
Mass General BrighamChestnut HillMassachusetts02467-

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By research site
Johns Hopkins School of Medicine· Baltimore, MDMass General Brigham· Chestnut Hill, MA

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