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TKA Melatonin and Sleep Quality

NCT05332717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-09-14

No results posted yet for this study

Summary

This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.

Conditions

  • Arthroplasty
  • Replacement
  • Knee
  • Sleep Initiation and Maintenance Disorders

Interventions

DIETARY_SUPPLEMENT

Melatonin 5 mg

Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

DIETARY_SUPPLEMENT

Placebo (Vitamin C)

Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Alejandro G Della Valle, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-01-31
Completion
2022-04-30

Countries

  • United States

Study Locations

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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 NCT05332717 on ClinicalTrials.gov