RecruitingNot ApplicableNCT06976138

Sleep TO Prevent Post-surgical Pain


Sponsor

Johns Hopkins University

Enrollment

252 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Inclusion Criteria4

  • 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

Exclusion Criteria12

  • 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

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Interventions

BEHAVIORALCognitive-Behavioral Therapy for Insomnia

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

DEVICEBright 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

DEVICENegative 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

BEHAVIORALSleep / Knee Osteoarthritis Education

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


Locations(2)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Mass General Brigham

Chestnut Hill, Massachusetts, United States

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NCT06976138


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