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

H

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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