NCT00592618

Brief Summary

Sleep studies in ESRD patients have identified increased prevalence of Sleep Apnea. Based on current knowledge, treatment aimed at reducing oxidative stress might improve Sleep Apnea in HD patients. The aim of our study is to investigate the effect of N-acetylsysteine on Sleep Apnea in HD patients.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

January 14, 2008

Status Verified

May 1, 2007

First QC Date

January 1, 2008

Last Update Submit

January 11, 2008

Conditions

ESRDSleep Apnea

Keywords

ESRDHemodialysisSleep Apnea

Interventions

Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeksDRUG

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include 20 patients with ESRD, treated with chronic hemodialysis in Assaf Harofeh Medical Center and suffering from sleep disturbances, such as frequent arousals, snoring, daytime sleepiness.

You may not qualify if:

  • Patients will be excluded from the study if they are:
  • Recently started treated with chronic dialysis: less than 3 months.
  • Survived recent major illness, requiring hospitalisation in the last 3 months.
  • Patients with acute renal failure
  • Currently treated with antioxidants ( NAC, vitamin E ets.)
  • Current use of sleep pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Division, Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Kidney Failure, ChronicSleep Apnea Syndromes

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Leonid S Feldman, MD

    Assaf Harofeh MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid S Feldman, MD

CONTACT

+972-8-9779383leonidf@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Last Updated

January 14, 2008

Record last verified: 2007-05

Locations

IL(1)