NCT01945801

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Lasilactone	Active drug (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.
DRUG	Placebo	The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-09-19
• Last updated: 2015-08-20

Locations

1 site across 1 country: Brazil