Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 13-0272 | Other Grant/Funding Number | Fund of Incentive of Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasilactone | Active Comparator | Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days. |
|
| placebo pill | Placebo Comparator | One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days. |
|
| Sodium-Restricted Diet | Active Comparator | The diet group will receive a regimen with a prescribed intake of three grams of sodium per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasilactone | Drug | Active drug (spironolactone 100 mg plus furosemide 20 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index | Number of apneas/hour | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Somnolence scale (Epworth) and ventilatory parameters | One week | |
| Glycolipid profile | Total and HDL Cholesterol, Triglycerides, and glucose | One week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Denis Martinez, MD, PhD | Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29669139 | Derived | Fiori CZ, Martinez D, Montanari CC, Lopez P, Camargo R, Sezera L, Goncalves SC, Fuchs FD. Diuretic or sodium-restricted diet for obstructive sleep apnea-a randomized trial. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy016. | |
| 25906818 | Derived | Fiori CZ, Martinez D, Goncalves SC, Montanari CC, Fuchs FD. Effect of diuretics and sodium-restricted diet on sleep apnea severity: study protocol for a randomized controlled trial. Trials. 2015 Apr 25;16:188. doi: 10.1186/s13063-015-0699-9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D005665 | Furosemide |
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
|
| Placebo | Drug | The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug. |
|
|
| Aldosterone Renin Level Activity | Serum renin and aldosterone | One week |
| Dosages of urinary 24h | Aldosterone, sodium, potassium, urea, and creatinine | One week |
| Inflammatory marker | C reactive protein | One week |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |