NCT01945801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

September 16, 2013

Last Update Submit

August 19, 2015

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apneaTreatmentSodium-Restricted DietDiureticLasilactone

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index

    Number of apneas/hour

    One week

Secondary Outcomes (5)

  • Somnolence scale (Epworth) and ventilatory parameters

    One week

  • Glycolipid profile

    One week

  • Aldosterone Renin Level Activity

    One week

  • Dosages of urinary 24h

    One week

  • Inflammatory marker

    One week

Study Arms (3)

Lasilactone

ACTIVE COMPARATOR

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

placebo pill

PLACEBO COMPARATOR

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

Drug: Placebo

Sodium-Restricted Diet

ACTIVE COMPARATOR

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

Other: Sodium-Restricted Diet

Interventions

LasilactoneDRUG

Active drug (spironolactone 100 mg plus furosemide 20 mg).

Also known as: Spironolactone 100 mg plus Furosemide 20 mg
Lasilactone
Sodium-Restricted DietOTHER

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.

Also known as: Low sodium diet
Sodium-Restricted Diet
PlaceboDRUG

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

Also known as: Placebo pill, Control
placebo pill

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29669139DERIVED

  • 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.

    PMID: 25906818DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

SpironolactoneFurosemideDiet, Sodium-Restricted

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSulfanilamidesSulfonamidesAmidesAniline CompoundsAminesSulfonesSulfur CompoundsDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Denis Martinez, MD, PhD

    Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

BR(1)