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

This study is currently recruiting participants.
Verified May 2013 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: March 19, 2014
Last verified: May 2013
  Purpose

Compare the effect of a low sodium diet to the diuretic in patients with severe obstructive sleep apnea.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ]
  • Lipid profile [ Time Frame: One week ] [ Designated as safety issue: No ]
    Total and HDL Cholesterol, Triglycerides,

  • Aldosterone-Renin and sodium and potassium balance [ Time Frame: One week ] [ Designated as safety issue: No ]
    Serum Aldosterone, renin, potassium, and sodium levels

  • Renal Function [ Time Frame: One week ] [ Designated as safety issue: No ]
    Urea and creatinine in urine

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

Estimated Enrollment: 54
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (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
No Intervention: Control
Active Comparator: Sodium-Restricted Diet
Recommendations to follow Sodium-Restricted Diet duration: one week
Other: Sodium-Restricted Diet

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Severe OSA with apnea-hypopnea index (AHI)>= 30/h
  • Body mass index = 19-34,9 kg/m2
  • Caucasians

Exclusion Criteria:

  • Use of CPAP
  • Systemic arterial hypertension
  • Established cardiovascular disease (myocardial infarction)
  • Stroke
  • Heart failure
  • Presence of tonsillar hypertrophy.
  • Use of more than one drug for hypertension
  • Secondary hypertension
  • Participation in other clinical trial in previous 6 months
  Contacts and Locations
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 Zappe Fiori, MSc    555133598289    cintiazfiori@gmail.com   
Principal Investigator: Cintia Z Fiori, MSc         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Denis Martinez, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Principal Investigator: Cintia Fiori, MSc Federal University of 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: March 19, 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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014