Clinical trial NCT01945801: Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
Official title: The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea
Treatment
Sodium-Restricted Diet
Diuretic
Lasilactone
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men in the age range from 18 to 60 years
* Full-night in-laboratory polysomnography with apnea-hypopnea index \> 30/h in the last three months
* Body mass index \< 35 kg/m2
* Informed consent

Exclusion Criteria:

* Already having started any treatment for sleep apnea, including use of continuous positive airway pressure
* NYHA heart failure, any class
* Predominantly central apnea
* Peripheral venous or lymphatic insufficiency
* Any chronic renal disease
* Use of diuretics and substances with action in the central or peripheral nervous system such as benzodiazepines, hypnotics, anticonvulsants, antidepressants, appetite suppressants, amphetamines, antiparkinson agents, muscle relaxants, bronchodilators
* Stroke within 6 months or with incapacitating sequelae
* Any physical, mental or social condition impairing the ability to participate in the trial

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: One week
Secondary outcomes:
measure: Somnolence scale (Epworth) and ventilatory parameters
timeFrame: One week
measure: Glycolipid profile
timeFrame: One week
measure: Aldosterone Renin Level Activity
timeFrame: One week
measure: Dosages of urinary 24h
timeFrame: One week
measure: Inflammatory marker
timeFrame: One week
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Denis Martinez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.