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Recruiting NCT06976138

Sleep TO Prevent Post-surgical Pain

No phase Interventional Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Behavioral Therapy for Insomnia, Bright Light therapy via the Re-Timer®, Negative Ion exposure via IonMi Device, Sleep / Knee Osteoarthritis Education.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

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]
Secondary outcome measures (5)
  • Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity [Time frame: immediately post surgery, 6 weeks post surgery]
  • Number of participants with Post-surgical opioid use [Time frame: 6-weeks post-surgery, 3 and 6 months post surgery]
  • Insomnia Severity as assessed by the Insomnia Severity Index [Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months]
  • Circadian Rest Activity Rhythm (RAR) assessed by actigraphy [Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months]
  • Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9) [Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Johns Hopkins School of Medicine — Baltimore
  • Mass General Brigham — Chestnut Hill

Identifiers

NCT: NCT06976138 · IRB00454253 · 1R01AG085712-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗