RECRUITING

Sleep TO Prevent Post-surgical Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sleep TO Prevent Post-surgical Pain

Quick Facts

Study Start:2025-06-23
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * People with knee osteoarthritis,
  2. * 60 years old and older,
  3. * scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
  4. * have trouble falling or staying asleep
  1. * currently using medications to help sleep
  2. * have completed Cognitive Behavioral Therapy for Insomnia
  3. * used either Bright Light or Negative Ion exposures in the past year
  4. * have an inflammatory rheumatologic disorder, seizure disorder
  5. * serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
  6. * serious sleep or circadian rhythm disorder, untreated sleep apnea
  7. * are pregnant or lactating
  8. * have retinal pathology
  9. * history of eye surgery (Lasik or cataract okay if more than 3 months ago)
  10. * are taking disease-modifying antirheumatic drugs
  11. * taking photosensitizing medications
  12. * are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling

Contacts and Locations

Study Contact

Anna Kim-Dahl
CONTACT
410-550-5704
akimdah1@jhu.edu
Marise Owens
CONTACT
617-732-9463
mcornelius@bwh.harvard.edu

Principal Investigator

Michael T Smith, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Helen Burgess, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan
Robert R Edwards, PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
United States
Mass General Brigham
Chestnut Hill, Massachusetts, 02467
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Michael T Smith, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Helen Burgess, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Robert R Edwards, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Knee Osteoarthristis