Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

NCT03879707 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 49586
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Conditions

Pain After TJA

Outcome Measures

Primary Outcomes (1)

• Effect of melatonin and magnesium on pain

  Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months.

  90 days

Secondary Outcomes (5)

• Effect of melatonin on daily activities

  90 days

• Effect of melatonin on daily activities

  90 days

• Effect of melatonin on daily activities

  90 days

• Effect of melatonin on daily activities

  90 days

• Effect of melatonin on daily activities

  90 days

Study Arms (2)

Experimental

EXPERIMENTAL

Melatonin and magnesium for 14 days

Drug: Melatonin 5 mg; Drug: Magnesium 500Mg Oral Tablet

Control

PLACEBO COMPARATOR

Placebo for 14 days

Drug: Placebo Oral Tablet

Interventions

Melatonin 5 mg DRUG

Melatonin is known to induce sleep

Experimental

Placebo Oral Tablet DRUG

Placebo

Control

Magnesium 500Mg Oral Tablet DRUG

Magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, a neurotransmitter that promotes sleep. Research indicates supplemental magnesium can improve sleep quality, especially in people with poor sleep

Experimental

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• No chronic pain
• Patients underwent revision or bilateral surgery.
• Patients underwent fracture.
• Patients suffering from dementia / delirium
• Patients on narcotics greater than 10mg hydrocodom before surgery
• Not willing to participate

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Melatonin; Magnesium; Tablets

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Derek Amanatullah, M.D. PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 19, 2019
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)