Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have 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.

Official Title
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A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

Conditions
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End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age > 18 and <85 years of age Patients with CKD or ESRD with eGFR < 30 mls/min If receiving hemodialysis, patients must be on treatment > 3 months Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements Exclusion Criteria: Patients receiving outpatient hemodialysis for < 3 months Patients with estimated GFR by Cockcroft Gault > 30 mls/min Patients receiving beta blocker therapy within one month of randomization Patients receiving Nifedipine therapy within one month randomization Patients on peritoneal dialysis Patient with chronic home oxygen supplementation Patients receiving chronic home CPAP therapy Patients actively receiving outpatient sleep medications Patients with diabetic gastroparesis unresponsive to medication Patients with known pregnancy or unwilling to use contraception during the course of the study Patients with a functioning renal allograft Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo controlled<br>comparison of placebo controlled to 1mg melatonin or 3mg melatonin | Drug: Melatonin<br>* patients will receive placebo, 1mg melatonin or 3mg melatonin<br>|
| Active Comparator: Melatonin<br>comparison of melatonin 1mg or melatonin 3mg | Drug: Melatonin<br>* patients will receive placebo, 1mg melatonin or 3mg melatonin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | Patients taking melatonin supplement, 1mg or 3mg daily, compared to placebo controlled group will be compared to see who group achieved a 25% reduction in sleep latency or 25% increase in total sleep time at the end of 60 days. Using the Pittsburg Sleep Quality Index (PSQI) questionnaire as the index to measure quality of sleep and sleep patterns. Study will also use Polysomnography testing that will record duration of sleep patterns. | Compare sleep duration at the end of 60 days |