Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea (DESALT)
|ClinicalTrials.gov Identifier: NCT01945801|
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : August 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Lasilactone Other: Sodium-Restricted Diet Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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
- Apnea-Hypopnea Index [ Time Frame: One week ]Number of apneas/hour
- Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ]
- Glycolipid profile [ Time Frame: One week ]Total and HDL Cholesterol, Triglycerides, and glucose
- Aldosterone Renin Level Activity [ Time Frame: One week ]Serum renin and aldosterone
- Dosages of urinary 24h [ Time Frame: One week ]Aldosterone, sodium, potassium, urea, and creatinine
- Inflammatory marker [ Time Frame: One week ]C reactive protein
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945801
|Hospital de Clinicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-903|
|Principal Investigator:||Denis Martinez, MD, PhD||Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul|