Clinical Trial Finder

Sleep TO Prevent Post-surgical Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06976138
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Johns Hopkins University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael T Smith, PhDHelen Burgess, PhDRobert R Edwards, PhD
Principal Investigator Affiliation Johns Hopkins UniversityUniversity of MichiganBrigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthristis
Additional Details

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 Negative Ion exposure combined with either Cognitive Behavioral Therapy for Insomnia or Sleep / Knee Osteoarthritis Education to reduce pain following total knee replacement surgery. This knowledge is needed to develop better ways to manage pain after surgery. Sleep problems are often not treated before or after surgery, so this may differ from the typical care received by adding a focus on sleep. People with knee osteoarthritis, who are 60 years old and older, who are scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and who have trouble falling or staying asleep, may join this study. There are two possible devices that are being compared in this study.

  • - If the participants are in the Morning Bright Light exposure group, the participants will use the Re-timer®, a wearable bright light exposure device.
This device is commercially available and in use by the general population. This device meets international ultraviolet and blue light hazard safety standards. The light intensities used in this study are greater than most indoor light, but much dimmer than sunlight on a bright day.
  • - If the participants are in the Negative Ionizer exposure group, the participants will use the IonPacific,"ionMi,"a wearable negative ionizer.
This device is also commercially available and in use by the general population. There have been reports of improved sleep and daytime symptoms associated with poor sleep for both Morning Bright Light and Negative Ionizer exposures. The use of Re-timer and IonMi in this research study is investigational. The word "investigational" means that the Re-timer and IonMi are not approved for marketing by the Food and Drug Administration (FDA). Participation includes: A virtual and in person screening and training visit 4, 1-hour long telehealth sessions scheduled each week before surgery 2, 30-minute telehealth sessions, 2-weeks after surgery and 3-months after surgery.This study will be using "blinding" which means only a few members of the study team will know what group / sleep program the participants have been assigned to until the study ends. In case of an emergency, the study doctor can quickly find out which sleep health program the participants have been assigned to receive. During parts of the study, the device the participants are using may be deactivated in order to test the effects of an active study device compared to a deactivated device. At the end of the study, the team can provide information about the timing of device deactivation. The participants will not be asked to change the clinical care currently being received for knee osteoarthritis.

Arms & Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins School of Medicine, Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

Johns Hopkins School of Medicine

Baltimore 4347778, Maryland 4361885, 21224

Site Contact

Anna Kim-Dahl

[email protected]

410-550-5704

Mass General Brigham, Chestnut Hill 4932957, Massachusetts 6254926

Status

Active, not recruiting

Address

Mass General Brigham

Chestnut Hill 4932957, Massachusetts 6254926, 02467

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