Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea (DESALT)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|