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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Lasilactone
* Other: Sodium-Restricted Diet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone