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

The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Lasilactone; Drug: Placebo; Other: Sodium-Restricted Diet

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
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Lasilactone; Active drug (spironolactone 100 mg plus furosemide 20 mg).; Other Names: Spironolactone 100 mg plus Furosemide 20 mg
Placebo Comparator: placebo pill; One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.	Drug: Placebo; The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.; Other Names: Control; Placebo pill
Active Comparator: Sodium-Restricted Diet; The diet group will receive a regimen with a prescribed intake of three grams of sodium per day	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 Names: Low sodium diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index	Number of apneas/hour	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Somnolence scale (Epworth) and ventilatory parameters		One week
Glycolipid profile	Total and HDL Cholesterol, Triglycerides, and glucose	One week
Aldosterone Renin Level Activity	Serum renin and aldosterone	One week
Dosages of urinary 24h	Aldosterone, sodium, potassium, urea, and creatinine	One week
Inflammatory marker	C reactive protein	One week

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Denis Martinez, MD, PhD, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

Publications and helpful links

General Publications

• Fiori CZ, Martinez D, Montanari CC, Lopez P, Camargo R, Sezera L, Goncalves 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, Goncalves 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Treatment; Diuretic; Sleep apnea; Sodium-Restricted Diet; Lasilactone
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Sodium Potassium Chloride Symporter Inhibitors; Spironolactone; Furosemide
• Other Study ID Numbers: GPPG-13-0272; 13-0272 (Other Grant/Funding Number: Fund of Incentive of Research)