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Effect of diuretics and sodium-restricted diet on sleep apnea severity: study protocol for a randomized controlled trial

Overview of attention for article published in Trials, April 2015
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Title
Effect of diuretics and sodium-restricted diet on sleep apnea severity: study protocol for a randomized controlled trial
Published in
Trials, April 2015
DOI 10.1186/s13063-015-0699-9
Pubmed ID
Authors

Cintia Zappe Fiori, Denis Martinez, Sandro Cadaval Gonçalves, Carolina Caruccio Montanari, Flavio Danni Fuchs

Abstract

Obstructive sleep apnea occurs as a result of increased collapsibility of the upper airway. Overnight fluid displacement from the legs to the neck causes pharyngeal narrowing and increased apnea severity. Sodium intake is associated with apnea severity. We hypothesized that interventions that decrease bodily fluid content might reduce the severity of sleep apnea. This is a randomized clinical trial including men with an apnea-hypopnea index greater than 30 events/hour, previously diagnosed by full-night in-laboratory polysomnography. A total of 54 men will be included and randomly assigned to three groups: Diuretic (n = 18), sodium-restricted diet (n = 18), and control (n = 18). The intervention will last one week. Intention-to-treat and per-protocol analyses will be performed. The diuretic group will receive combined spironolactone 100 mg plus furosemide 20 mg daily, taken in the morning. The diet group will receive a regimen with a maximum intake of 3 g of sodium per day. The control group will receive a placebo pill and will maintain all eating habits while keeping a recall diary of their dietary behavior. The primary outcome measure will be change in apnea-hypopnea index. The secondary outcome measures will be variations of: anthropometric and bioelectrical impedance variables, office blood pressure, respiratory variables from in-home level III polysomnography, excessive daytime sleepiness, glycolipid profile, C-reactive protein, 24 h urinary variables, and adverse events. Despite the high efficacy of continuous positive airway pressure to reverse upper airway obstruction in sleep apnea, partial adherence to this form of treatment reduces its efficiency. Thus, additional forms of treating apnea need to be investigated. If the results of this proof-of-concept trial show that decreases in bodily fluid content, either by diuretic or dietary intervention, reduces the severity of sleep apnea, further investigation will be necessary before these results can be translated and adopted as an adjunct apnea therapy. clinicaltrials.gov NCT01945801.

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The data shown below were compiled from readership statistics for 73 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 73 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 12 16%
Student > Bachelor 12 16%
Student > Postgraduate 6 8%
Student > Ph. D. Student 5 7%
Other 4 5%
Other 11 15%
Unknown 23 32%
Readers by discipline Count As %
Medicine and Dentistry 27 37%
Nursing and Health Professions 11 15%
Pharmacology, Toxicology and Pharmaceutical Science 3 4%
Psychology 3 4%
Computer Science 1 1%
Other 5 7%
Unknown 23 32%