Chronic Kidney Disease, End Stage Renal Disease, Sleep Disorder
Conditions
Brief 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.
Interventions
DRUGMelatonin
patients will receive placebo, 1mg melatonin or 3mg melatonin
Sponsors
Southeast Renal Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patient age \> 18 and \<85 years of age 2. Patients with CKD or ESRD with eGFR \< 30 mls/min 3. If receiving hemodialysis, patients must be on treatment \> 3 months 4. 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
1. Patients receiving outpatient hemodialysis for \< 3 months 2. Patients with estimated GFR by Cockcroft Gault \> 30 mls/min 3. Patients receiving beta blocker therapy within one month of randomization 4. Patients receiving Nifedipine therapy within one month randomization 5. Patients on peritoneal dialysis 6. Patient with chronic home oxygen supplementation 7. Patients receiving chronic home CPAP therapy 8. Patients actively receiving outpatient sleep medications 9. Patients with diabetic gastroparesis unresponsive to medication 10. Patients with known pregnancy or unwilling to use contraception during the course of the study 11. Patients with a functioning renal allograft 12. Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial 13. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Compare sleep duration at the end of 60 days | 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. |
Countries
United States
Contacts
Primary ContactJames A Tumlin, MD
Backup ContactJeremy Whitson
Outcome results
None listed