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Hormone Therapy

Melatonin for Sleep Disorders

Phase 2 & 3
Waitlist Available
Led By James A Tumlin, MD
Research Sponsored by Southeast Renal Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare sleep duration at the end of 60 days
Awards & highlights

Study Summary

The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

Eligible Conditions
  • Sleep Disorders
  • Kidney Failure
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare sleep duration at the end of 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare sleep duration at the end of 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Objective

Trial Design

2Treatment groups
Active Control
Group I: Placebo controlledActive Control1 Intervention
comparison of placebo controlled to 1mg melatonin or 3mg melatonin
Group II: MelatoninActive Control1 Intervention
comparison of melatonin 1mg or melatonin 3mg

Find a Location

Who is running the clinical trial?

Southeast Renal Research InstituteLead Sponsor
6 Previous Clinical Trials
45 Total Patients Enrolled
James A Tumlin, MDPrincipal InvestigatorSoutheast Renal Research Institute
6 Previous Clinical Trials
1,030 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
2012. "Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01922999.
All > Sleep Disorder > Melatonin
~4 spots leftby Apr 2025
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