Recruiting

Cognitive Behavioral Therapy & Light Exposure

Sponsor:

Johns Hopkins University

Code:

NCT06976138

Conditions

Knee Osteoarthristis

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Insomnia

Bright Light therapy via the Re-Timer®

Negative Ion exposure via IonMi Device

Sleep / Knee Osteoarthritis Education

Study Details

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.

Conditions

Knee Osteoarthristis

Study ID

NCT06976138

Start date

Jun 13, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Cognitive-Behavioral Therapy for Insomnia

This program will focus on changing the participant's sleep patterns, activities, and habits.

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

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

Sleep / Knee Osteoarthritis Education

This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.

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 and Locations

Central contacts

Anna Kim-Dahl

410-550-5704akimdah1@jhu.edu

Marise Owens

617-732-9463mcornelius@bwh.harvard.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Anna Kim-Dahl

410-550-5704akimdah1@jhu.edu

Heavon Allen

4105501000hallen16@jhmi.edu

Principal Investigator:

Michael T Smith, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • total knee arthroplasty
  • knee replacement
  • koa
  • knee osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-07.