NCT01922999

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Southeast Renal Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• End Stage Renal Disease
• Chronic Kidney Disease
• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Melatonin	patients will receive placebo, 1mg melatonin or 3mg melatonin

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-08-14
• Last updated: 2017-01-24

Locations

1 site across 1 country: United States