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Completed

NCT Number: NCT01945801

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lasilactone

Drug

Active drug (spironolactone 100 mg plus furosemide 20 mg).

Other names: Spironolactone 100 mg plus Furosemide 20 mg

Sodium-Restricted Diet

Other

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.

Other names: Low sodium diet

Placebo

Drug

The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.

Other names: Placebo pill, Control

Primary outcomes

  1. Apnea-Hypopnea Index

    Time frame: One week

    Number of apneas/hour

Secondary outcomes

  1. Somnolence scale (Epworth) and ventilatory parameters

    Time frame: One week

  2. Glycolipid profile

    Time frame: One week

    Total and HDL Cholesterol, Triglycerides, and glucose

  3. Aldosterone Renin Level Activity

    Time frame: One week

    Serum renin and aldosterone

  4. Dosages of urinary 24h

    Time frame: One week

    Aldosterone, sodium, potassium, urea, and creatinine

  5. Inflammatory marker

    Time frame: One week

    C reactive protein

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Acronym: DESALT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2013
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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