Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea (DESALT)
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.
Obstructive Sleep Apnea
Other: Sodium-Restricted Diet
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study|
- Apnea-Hypopnea Index [ Time Frame: One week ] [ Designated as safety issue: No ]Number of apneas/hour
- Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ] [ Designated as safety issue: No ]
- Glycolipid profile [ Time Frame: One week ] [ Designated as safety issue: No ]Total and HDL Cholesterol, Triglycerides, and glucose
- Aldosterone Renin Level Activity [ Time Frame: One week ] [ Designated as safety issue: No ]Serum renin and aldosterone
- Dosages of urinary 24h [ Time Frame: One week ] [ Designated as safety issue: No ]Aldosterone, sodium, potassium, urea, and creatinine
- Inflammatory marker [ Time Frame: One week ] [ Designated as safety issue: No ]C reactive protein
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Lasilactone
Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.
Active drug (spironolactone 100 mg plus furosemide 20 mg).
Other Name: Spironolactone 100 mg plus Furosemide 20 mg
Placebo Comparator: placebo pill
One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
Active Comparator: Sodium-Restricted Diet
The diet group will receive a regimen with a prescribed intake of three grams of sodium per day
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.
Other Name: Low sodium diet
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945801
|Contact: Cintia Fiori, MScfirstname.lastname@example.org|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-903|
|Contact: Cintia Z Fiori, MSc 5551 email@example.com|
|Principal Investigator: Cintia Z Fiori, MSc|
|Principal Investigator:||Denis Martinez, MD, PhD||Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul|