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

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ClinicalTrials.gov Identifier: NCT01945801
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: One week ]
    Number of apneas/hour


Secondary Outcome Measures :
  1. Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: One week ]
  2. Glycolipid profile [ Time Frame: One week ]
    Total and HDL Cholesterol, Triglycerides, and glucose

  3. Aldosterone Renin Level Activity [ Time Frame: One week ]
    Serum renin and aldosterone

  4. Dosages of urinary 24h [ Time Frame: One week ]
    Aldosterone, sodium, potassium, urea, and creatinine

  5. Inflammatory marker [ Time Frame: One week ]
    C reactive protein



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945801


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01945801     History of Changes
Other Study ID Numbers: GPPG-13-0272
13-0272 ( Other Grant/Funding Number: Fund of Incentive of Research )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

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

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