Obstructive Sleep ApneaPhase 4DESALTNCT01945801
Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
A Phase 4 study testing Lasilactone and Sodium-Restricted Diet in people with Obstructive Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Lasilactone and Sodium-Restricted Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
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.
Read the 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
- Being tested
- Lasilactone, Sodium-Restricted Diet, Placebo
- Keywords
- Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasilactoneDrug
Also called Spironolactone 100 mg plus Furosemide 20 mg
Active drug (spironolactone 100 mg plus furosemide 20 mg).
Sodium-Restricted DietOther
Also called Low sodium 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.
PlaceboDrug
Also called Placebo pill, Control
The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lasilactone |
| placebo pill | Placebo comparator | One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days. Receives: 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 Receives: Other: Sodium-Restricted Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
Number of apneas/hour
Measured: One week
Secondary outcomes (5)
Somnolence scale (Epworth) and ventilatory parameters
Measured: One week
Glycolipid profile
Total and HDL Cholesterol, Triglycerides, and glucose
Measured: One week
Aldosterone Renin Level Activity
Serum renin and aldosterone
Measured: One week
Dosages of urinary 24h
Aldosterone, sodium, potassium, urea, and creatinine
Measured: One week
Inflammatory marker
C reactive protein
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Martinez, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945801
- Sponsor's protocol ID
- GPPG-13-0272
- Other IDs
- 13-0272
- Acronym
- DESALT
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29669139Fiori 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.
PubMed 25906818
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
- ClinicalTrials.gov ID
- NCT01945801
- Acronym / sponsor ID
- DESALT / GPPG-13-0272
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep apnea, Treatment, Sodium-Restricted Diet, Diuretic, Lasilactone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lasilactone | Active comparator | Drug: LasilactoneDosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days. |
| placebo pill | Placebo comparator | Drug: PlaceboOne capsule taking in the morning. Frequency and duration: One capsule daily for 7 days. |
| Sodium-Restricted Diet | Active comparator | Other: Sodium-Restricted DietThe diet group will receive a regimen with a prescribed intake of three grams of sodium per day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LasilactoneAlso: Spironolactone 100 mg plus Furosemide 20 mgActive drug (spironolactone 100 mg plus furosemide 20 mg). | Drug | Lasilactone |
| Sodium-Restricted DietAlso: Low sodium dietThe 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 | Sodium-Restricted Diet |
| PlaceboAlso: Placebo pill, ControlThe placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug. | Drug | placebo pill |
Primary outcome
Apnea-Hypopnea Index
Time frame: One week
Number of apneas/hour
5 secondary outcomes
Somnolence scale (Epworth) and ventilatory parameters
Time frame: One week
Glycolipid profile
Time frame: One week
Aldosterone Renin Level Activity
Time frame: One week
Dosages of urinary 24h
Time frame: One week
Inflammatory marker
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 29669139Fiori 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.
- Derived from this study: PubMed 25906818Fiori 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.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Martinez, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lasilactone and Sodium-Restricted Diet in people with Obstructive Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01945801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.