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

NCT ID: NCT01945801

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lasilactone

Intervention Type: DRUG

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

placebo pill

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Sodium-Restricted Diet

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

Group Type: ACTIVE_COMPARATOR

Sodium-Restricted Diet

Intervention Type: OTHER

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.

Interventions

Lasilactone

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Spironolactone 100 mg plus Furosemide 20 mg; Low sodium diet; Placebo pill; Control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Martinez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 29669139 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25906818 (View on PubMed)

Other Identifiers

13-0272

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GPPG-13-0272

Identifier Type: -

Identifier Source: org_study_id