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

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Lasilactone; Other: Sodium-Restricted Diet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01945801

13-0272 (Other Grant/Funding Number)

GPPG-13-0272

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 3 patient groups, including a placebo group

Lasilactone

Active Comparator group

Description:

Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.

Treatment:

Drug: Lasilactone

placebo pill

Placebo Comparator group

Description:

One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.

Treatment:

Drug: Placebo

Sodium-Restricted Diet

Active Comparator group

Description:

The diet group will receive a regimen with a prescribed intake of three grams of sodium per day

Treatment:

Other: Sodium-Restricted Diet