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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Lasilactone; Other: Sodium-Restricted Diet; Drug: Placebo

• Registration Number: NCT01945801
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lasilactone	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.
Sodium-Restricted Diet	Sodium-Restricted Diet	The diet group will receive a regimen with a prescribed intake of three grams of sodium per day
placebo pill	Placebo	One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	One week	Number of apneas/hour

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil