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Sleep TO Prevent Post-surgical Pain

NCT06976138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-06-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Michael T Smith, PhD · Johns Hopkins University

  • Helen Burgess, PhD · University of Michigan

  • Robert R Edwards, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976138 on ClinicalTrials.gov