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

• ClinicalTrials.gov Identifier: NCT01945801
• Recruitment Status: Completed
• First Posted: September 19, 2013
• Last Update Posted: August 20, 2015
• Sponsor: Hospital de Clinicas de Porto Alegre
• Information provided by (Responsible Party): Hospital de Clinicas de Porto Alegre

Tracking Information

• First Submitted Date: September 16, 2013
• First Posted Date: September 19, 2013
• Last Update Posted Date: August 20, 2015
• Study Start Date: October 2013
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2013)

Apnea-Hypopnea Index [ Time Frame: One week ]

Number of apneas/hour

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obstructive Sleep Apnea

Intervention

• 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

• 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 *

• Fiori CZ, Martinez D, Montanari CC, Lopez P, Camargo R, Sezerá L, Gonçalves SC, Fuchs FD. Diuretic or sodium-restricted diet for obstructive sleep apnea-a randomized trial. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy016.
• Fiori CZ, Martinez D, Gonçalves SC, Montanari CC, Fuchs FD. Effect of diuretics and sodium-restricted diet on sleep apnea severity: study protocol for a randomized controlled trial. Trials. 2015 Apr 25;16:188. doi: 10.1186/s13063-015-0699-9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2013): 54
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2015
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01945801
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Hospital de Clinicas de Porto Alegre
• Study Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Not Provided

Investigators

• 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