Obstructive Sleep Apnea
Conditions
Keywords
Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone
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.
Interventions
DRUGLasilactone
Active drug (spironolactone 100 mg plus furosemide 20 mg).
OTHERSodium-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.
DRUGPlacebo
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index | One week | Number of apneas/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Somnolence scale (Epworth) and ventilatory parameters | One week | — |
| Glycolipid profile | One week | Total and HDL Cholesterol, Triglycerides, and glucose |
| Aldosterone Renin Level Activity | One week | Serum renin and aldosterone |
| Dosages of urinary 24h | One week | Aldosterone, sodium, potassium, urea, and creatinine |
| Inflammatory marker | One week | C reactive protein |
Countries
Brazil
Outcome results
None listed