Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— DESALT  

Official title:

The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945801
• Other study ID #: GPPG-13-0272
• Secondary ID: 13-0272
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2013
• Last updated: August 19, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Lasilactone
Active drug (spironolactone 100 mg plus furosemide 20 mg).

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.

Drug:
• Placebo
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index	Number of apneas/hour	One week	No
Secondary	Somnolence scale (Epworth) and ventilatory parameters		One week	No
Secondary	Glycolipid profile	Total and HDL Cholesterol, Triglycerides, and glucose	One week	No
Secondary	Aldosterone Renin Level Activity	Serum renin and aldosterone	One week	No
Secondary	Dosages of urinary 24h	Aldosterone, sodium, potassium, urea, and creatinine	One week	No
Secondary	Inflammatory marker	C reactive protein	One week	No