search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Lasilactone
Sodium-Restricted Diet
Placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Lasilactone

placebo pill

Sodium-Restricted Diet

Arm Description

Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.

One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.

The diet group will receive a regimen with a prescribed intake of three grams of sodium per day

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
Number of apneas/hour

Secondary Outcome Measures

Somnolence scale (Epworth) and ventilatory parameters
Glycolipid profile
Total and HDL Cholesterol, Triglycerides, and glucose
Aldosterone Renin Level Activity
Serum renin and aldosterone
Dosages of urinary 24h
Aldosterone, sodium, potassium, urea, and creatinine
Inflammatory marker
C reactive protein

Full Information

First Posted
September 16, 2013
Last Updated
August 19, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT01945801
Brief Title
Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
Acronym
DESALT
Official Title
The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasilactone
Arm Type
Active Comparator
Arm Description
Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.
Arm Title
placebo pill
Arm Type
Placebo Comparator
Arm Description
One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.
Arm Title
Sodium-Restricted Diet
Arm Type
Active Comparator
Arm Description
The diet group will receive a regimen with a prescribed intake of three grams of sodium per day
Intervention Type
Drug
Intervention Name(s)
Lasilactone
Other Intervention Name(s)
Spironolactone 100 mg plus Furosemide 20 mg
Intervention Description
Active drug (spironolactone 100 mg plus furosemide 20 mg).
Intervention Type
Other
Intervention Name(s)
Sodium-Restricted Diet
Other Intervention Name(s)
Low sodium diet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo pill, Control
Intervention Description
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Number of apneas/hour
Time Frame
One week
Secondary Outcome Measure Information:
Title
Somnolence scale (Epworth) and ventilatory parameters
Time Frame
One week
Title
Glycolipid profile
Description
Total and HDL Cholesterol, Triglycerides, and glucose
Time Frame
One week
Title
Aldosterone Renin Level Activity
Description
Serum renin and aldosterone
Time Frame
One week
Title
Dosages of urinary 24h
Description
Aldosterone, sodium, potassium, urea, and creatinine
Time Frame
One week
Title
Inflammatory marker
Description
C reactive protein
Time Frame
One week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Martinez, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29669139
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.
Results Reference
derived
PubMed Identifier
25906818
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs