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Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea (DESALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945801
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 19, 2013
Last Update Posted Date August 20, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Apnea-Hypopnea Index [ Time Frame: One week ]
Number of apneas/hour
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ]
  • Glycolipid profile [ Time Frame: One week ]
    Total and HDL Cholesterol, Triglycerides, and glucose
  • Aldosterone Renin Level Activity [ Time Frame: One week ]
    Serum renin and aldosterone
  • Dosages of urinary 24h [ Time Frame: One week ]
    Aldosterone, sodium, potassium, urea, and creatinine
  • Inflammatory marker [ Time Frame: One week ]
    C reactive protein
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
  • Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ]
  • Lipid profile [ Time Frame: One week ]
    Total and HDL Cholesterol, Triglycerides,
  • Aldosterone-Renin and sodium and potassium balance [ Time Frame: One week ]
    Serum Aldosterone, renin, potassium, and sodium levels
  • Renal Function [ Time Frame: One week ]
    Urea and creatinine in urine
  • C reactive protein [ Time Frame: One week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
Official Title  ICMJE The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
Brief Summary This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3) placebo pill in the treatment of obstructive sleep apnea in adults.
Detailed Description Men with apnea-hypopnea index greater than 30/hour will be included and randomly assigned into three groups: sodium-restricted diet, or diuretic, or control. The intervention will last one week. The diuretic group will receive combined spironolactone 100mg plus furosemide 20mg daily. The diet group will receive a regimen with a maximum intake of three grams of sodium per day. The control group will receive a placebo pill and will maintain all eating habits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Drug: Lasilactone
    Active drug (spironolactone 100 mg plus furosemide 20 mg).
    Other Name: Spironolactone 100 mg plus Furosemide 20 mg
  • Other: Sodium-Restricted Diet
    The sodium-restricted diet will enforce some rules: do not use salt in cooking; do not use the salt shaker; do not ingest any industrialized food; to eat fresh salads and vegetables; do not add high-sodium seasonings, among others. The complete dietary rules will be delivered to each volunteer in a four page handout.
    Other Name: Low sodium diet
  • Drug: Placebo
    The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
    Other Names:
    • Placebo pill
    • Control
Study Arms  ICMJE
  • Active Comparator: Lasilactone
    Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.
    Intervention: Drug: Lasilactone
  • Placebo Comparator: placebo pill
    One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.
    Intervention: Drug: Placebo
  • Active Comparator: Sodium-Restricted Diet
    The diet group will receive a regimen with a prescribed intake of three grams of sodium per day
    Intervention: Other: Sodium-Restricted Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2013)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men in the age range from 18 to 60 years
  • Full-night in-laboratory polysomnography with apnea-hypopnea index > 30/h in the last three months
  • Body mass index < 35 kg/m2
  • Informed consent

Exclusion Criteria:

  • Already having started any treatment for sleep apnea, including use of continuous positive airway pressure
  • NYHA heart failure, any class
  • Predominantly central apnea
  • Peripheral venous or lymphatic insufficiency
  • Any chronic renal disease
  • Use of diuretics and substances with action in the central or peripheral nervous system such as benzodiazepines, hypnotics, anticonvulsants, antidepressants, appetite suppressants, amphetamines, antiparkinson agents, muscle relaxants, bronchodilators
  • Stroke within 6 months or with incapacitating sequelae
  • Any physical, mental or social condition impairing the ability to participate in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945801
Other Study ID Numbers  ICMJE GPPG-13-0272
13-0272 ( Other Grant/Funding Number: Fund of Incentive of Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Denis Martinez, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP