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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01945801
First received: September 16, 2013
Last updated: December 30, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Drug: Lasilactone
Other: Sodium-Restricted Diet
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Apnea-Hypopnea Index [ Time Frame: One week ] [ Designated as safety issue: No ]
    Number of apneas/hour


Secondary Outcome Measures:
  • Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ] [ Designated as safety issue: No ]
  • Glycolipid profile [ Time Frame: One week ] [ Designated as safety issue: No ]
    Total and HDL Cholesterol, Triglycerides, and glucose

  • Aldosterone Renin Level Activity [ Time Frame: One week ] [ Designated as safety issue: No ]
    Serum renin and aldosterone

  • Dosages of urinary 24h [ Time Frame: One week ] [ Designated as safety issue: No ]
    Aldosterone, sodium, potassium, urea, and creatinine

  • Inflammatory marker [ Time Frame: One week ] [ Designated as safety issue: No ]
    C reactive protein


Estimated Enrollment: 54
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Lasilactone
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.
Drug: Placebo
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
Other Names:
  • Placebo pill
  • Control
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945801

Contacts
Contact: Cintia Fiori, MSc 555133598289 cintiazfiori@gmail.com

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Cintia Z Fiori, MSc    5551    cintiazfiori@gmail.com   
Principal Investigator: Cintia Z Fiori, MSc         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Denis Martinez, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01945801     History of Changes
Other Study ID Numbers: GPPG-13-0272, 13-0272
Study First Received: September 16, 2013
Last Updated: December 30, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
Sleep apnea
Treatment
Sodium-Restricted Diet
Diuretic
Lasilactone

Additional relevant MeSH terms:
Sodium Potassium Chloride Symporter Inhibitors
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Diuretics
Furosemide
Spironolactone
Cardiovascular Agents
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 20, 2015