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Recruiting NCT06976138

NCT06976138 Sleep TO Prevent Post-surgical Pain

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Clinical Trial Summary
NCT ID NCT06976138
Status Recruiting
Phase
Sponsor Johns Hopkins University
Condition Knee Osteoarthristis
Study Type INTERVENTIONAL
Enrollment 252 participants
Start Date 2025-06-13
Primary Completion 2029-07-31

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Cognitive-Behavioral Therapy for InsomniaBright Light therapy via the Re-Timer®Negative Ion exposure via IonMi Device

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 252 participants in total. It began in 2025-06-13 with a primary completion date of 2029-07-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Anna Kim-Dahl

✉ akimdah1@jhu.edu

📞 410-550-5704

Principal Investigator

Michael T Smith, PhD

PRINCIPAL INVESTIGATOR

Johns Hopkins University

Frequently Asked Questions

Who can join the NCT06976138 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06976138 currently recruiting?

Yes, NCT06976138 is actively recruiting participants. Contact the research team at akimdah1@jhu.edu for enrollment information.

Where is the NCT06976138 trial being conducted?

This trial is being conducted at Baltimore, United States, Chestnut Hill, United States.

Who is sponsoring the NCT06976138 clinical trial?

NCT06976138 is sponsored by Johns Hopkins University. The principal investigator is Michael T Smith, PhD at Johns Hopkins University. The trial plans to enroll 252 participants.

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