Obstructive Sleep Apnea (OSA)HF(L)OSANCT07556094
Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.
A study testing Empagliflozin and Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea (OSA) and Sleep Apnea Syndrome, Obstructive, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The goal of this randomized clinical trial was to evaluate the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i) on sleep and cardiac outcomes in adults with heart failure (HF) and obstructive sleep apnea syndrome (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Sleep Apnea Syndrome, Obstructive, Heart Failure
- What is being tested?
- Empagliflozin and Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jun 2023to 9 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosed heart failure (HF) on stable guideline-directed medical therapy
- Obstructive sleep apnea (OSA) confirmed by sleep study (mild, moderate, or severe)
- No prior treatment with empagliflozin or other sodium-glucose cotransporter-2 inhibitors
- No prior treatment with continuous positive airway pressure therapy
- Body mass index (BMI) <40 kg/m²
- Clinical eligibility for CPAP therapy according to current recommendations
- Ability to provide written informed consent
Who cannot join
- Age <18 years
- Body mass index (BMI) ≥40 kg/m²
- Active malignancy
- Severe renal impairment (estimated glomerular filtration rate <25 mL/min/1.73 m²)
- Advanced hepatic insufficiency
- Symptomatic hypotension
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- Clinically significant volume depletion or dehydration
- Known hypersensitivity to empagliflozin or any component of the study medication
- Any condition that, in the opinion of the investigator, could interfere with study participation or interpretation of results
Trial locations and contacts
1 site in 1 country.
Poland1 site
University Clinical Hospital in Białystok
Bialystok, Podlaskie Voivodeship, 15-276
About this study
Official title: Effects of Empagliflozin and Continuous Positive Airway Pressure on Sleep, Cardiac Function, Oxidative Stress Markers, and Patient-Reported Outcomes in Adults With Heart Failure and Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial.
The goal of this randomized clinical trial was to evaluate the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i) on sleep and cardiac outcomes in adults with heart failure (HF) and obstructive sleep apnea syndrome (OSA). The study also examined how subsequent initiation of continuous positive airway pressure (CPAP) therapy affected sleep and cardiac outcomes, and whether response to treatment differed according to baseline obstructive sleep apnea severity.
The main questions it aims to answer were:
Read more
- Does empagliflozin affect sleep apnea severity and nocturnal oxygenation before CPAP initiation?
- Does prior empagliflozin treatment influence the response to subsequent CPAP therapy?
- Does empagliflozin affect oxidative stress markers, including total oxidative status (TOS), total antioxidant status (TAS), and oxidative stress index (OSI)?
- Does CPAP therapy initiation affect cardiac outcomes in both groups?
- Does response to treatment differ according to baseline obstructive sleep apnea severity, including mild, moderate, and severe disease?
Researchers compared participants receiving empagliflozin in addition to background HF therapy with those continuing background HF therapy without empagliflozin to evaluate the effects of empagliflozin.
Participants:
- Were randomly assigned to receive empagliflozin plus background HF pharmacotherapy or background HF pharmacotherapy therapy without empagliflozin
- Underwent sleep studies, transthoracic echocardiography and clinical assessments at baseline, 3 months, and 6 months.
- Provided blood samples for measurement of cardiac biomarkers and oxidative stress markers.
- Completed standardized questionnaires assessing sleep quality and symptoms.
- Initiated CPAP therapy after 3 months and continued treatment until the end of the study.
Read the detailed description
Heart failure and obstructive sleep apnea frequently coexist and are linked through complex pathophysiological mechanisms, including intermittent hypoxemia, sympathetic activation, oxidative stress, and hemodynamic alterations. This bidirectional interaction contributes to disease progression, impaired quality of life, and adverse clinical outcomes. While CPAP remains the standard treatment for OSA, treatment response in patients with coexisting HF is variable, and additional therapeutic strategies targeting both conditions are of clinical interest.
Sodium-glucose cotransporter-2 inhibitors, including empagliflozin, have demonstrated significant cardiovascular benefits in patients with HF. Their mechanisms of action, including osmotic diuresis, reduction in intravascular and interstitial fluid volume, and improvement in cardiac function, may also influence the pathophysiology of OSA, particularly by reducing nocturnal rostral fluid shift and upper airway collapsibility. However, prospective randomized data evaluating the effects of SGLT2i on sleep-disordered breathing in patients with HF and OSA remain limited.
This randomized controlled clinical trial was designed to evaluate the effects of empagliflozin on sleep, cardiac, and biochemical outcomes in adults with coexisting HF and OSA, and to assess the impact of subsequent CPAP therapy. The study incorporated a sequential two-phase design to allow differentiation between the early effects of pharmacological therapy and the later effects of CPAP.
In the first phase (0-3 months), participants were randomly assigned in a 1:1 ratio to receive empagliflozin in addition to background HF therapy or to continue background HF therapy without empagliflozin. This phase was designed to evaluate the isolated effect of empagliflozin on OSA severity, nocturnal oxygenation, cardiac function, and oxidative stress.
In the second phase (3-6 months), CPAP therapy was initiated in all participants, while empagliflozin treatment was continued in the study group. This phase was designed to assess the effect of CPAP therapy in both groups and to explore whether prior exposure to empagliflozin influenced the response to CPAP.
Assessments were performed at baseline, 3 months, and 6 months. Sleep-related outcomes included apnea-hypopnea index (AHI), mean oxygen saturation (MOS), lowest oxygen saturation (LOS), and time spent with oxygen saturation below 90% (T<90%), obtained from type III sleep studies. Cardiac outcomes included left ventricular ejection fraction assessed by transthoracic echocardiography and N-terminal pro-B-type natriuretic peptide concentrations. Biochemical analyses included evaluation of oxidative stress markers, including TOS, TAS, and OSI. Patient-reported outcomes included validated questionnaires assessing sleep quality, daytime sleepiness, and quality of life.
The study also included exploratory analyses to assess relationships between sleep-related and cardiac parameters, as well as to evaluate whether baseline OSA severity influenced response to treatment. The sequential design of the study allowed assessment of phase-specific effects and potential interaction between pharmacological therapy and CPAP.
Overall, the study aimed to provide a comprehensive evaluation of the role of empagliflozin as an adjunctive therapy in patients with HF and OSA, and to clarify its potential impact on sleep-disordered breathing, cardiac function, and oxidative stress in the context of subsequent CPAP treatment.
- Being tested
- Empagliflozin, Continuous Positive Airway Pressure (CPAP)
- Keywords
- sleep, sleep apnea, apnea, obstructive sleep apnea, heart, heart failure
- Medical subject headings
- Sleep Apnea, Obstructive, Heart Failure, Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin was initiated at baseline at a dose of 10 mg once daily, administered orally, in addition to background heart failure therapy, and continued throughout the 6-month study period.
Continuous Positive Airway Pressure (CPAP)Device
Continuous positive airway pressure therapy was initiated after 3 months in all participants using standard clinical practice. CPAP was applied nightly during sleep, with pressure settings individually titrated. The mean therapeutic pressure was approximately 15.5 ± 2.5 cm H₂O. Treatment was continued until the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin + Background Heart Failure Therapy | Experimental | Participants with HF and OSA initiated empagliflozin at baseline in addition to background heart failure therapy and continued treatment throughout the 6-month study period. During the first phase (0-3 months), the effects of empagliflozin were assessed. Continuous positive airway pressure therapy was initiated after 3 months and continued until the end of the study.
This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy. Receives: Drug: Empagliflozin; Device: Continuous Positive Airway Pressure (CPAP) |
| Background Heart Failure Therapy Without Empagliflozin | Active comparator | Participants continued background heart failure therapy without empagliflozin. Continuous positive airway pressure (CPAP) therapy was initiated after 3 months and continued until the end of the study. This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-Hypopnea Index (AHI).
Change in AHI, measured as the number of apnea and hypopnea events per hour of sleep, assessed between baseline and follow-up visits at 3 and 6 months.
Measured: Baseline, 3 months, and 6 months.
Secondary outcomes (1)
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations.
Change in NT-proBNP concentrations (pg/mL) measured in serum between baseline and follow-up visits.
Measured: Baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 Jun 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group randomized controlled trial with a sequential two-phase design. Participants were randomized 1:1 to receive empagliflozin in addition to background heart failure therapy or to continue background therapy without empagliflozin. During the first phase (0-3 months), the effect of empagliflozin was assessed. During the second phase (3-6 months), continuous positive airway pressure (CPAP) therapy was initiated in all participants, while empagliflozin was continued in the intervention group, allowing evaluation of CPAP effects and the influence of prior empagliflozin exposure on treatment response. The sequential design allowed separation of early pharmacological effects from later CPAP-driven improvements and enabled assessment of whether prior SGLT2 inhibition modifies subsequent response to CPAP therapy.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Polecka, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556094
- Sponsor's protocol ID
- APK.002.526.2022
- Acronym
- HF(L)OSA
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet determined whether individual participant data will be made available. Data sharing plans will be considered after completion of primary and secondary analyses and publication of study results, in accordance with institutional policies and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin and Continuous Positive Airway Pressure on Sleep, Cardiac Function, Oxidative Stress Markers, and Patient-Reported Outcomes in Adults With Heart Failure and Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07556094
- Acronym / sponsor ID
- HF(L)OSA / APK.002.526.2022
- Keywords
- sleep, sleep apnea, apnea, obstructive sleep apnea, heart, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- 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.
The goal of this randomized clinical trial was to evaluate the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i) on sleep and cardiac outcomes in adults with heart failure (HF) and obstructive sleep apnea syndrome (OSA). The study also examined how subsequent initiation of continuous positive airway pressure (CPAP) therapy affected sleep and cardiac outcomes, and whether response to treatment differed according to baseline obstructive sleep apnea severity.
The main questions it aims to answer were:
- Does empagliflozin affect sleep apnea severity and nocturnal oxygenation before CPAP initiation?
- Does prior empagliflozin treatment influence the response to subsequent CPAP therapy?
- Does empagliflozin affect oxidative stress markers, including total oxidative status (TOS), total antioxidant status (TAS), and oxidative stress index (OSI)?
- Does CPAP therapy initiation affect cardiac outcomes in both groups?
- Does response to treatment differ according to baseline obstructive sleep apnea severity, including mild, moderate, and severe disease?
Researchers compared participants receiving empagliflozin in addition to background HF therapy with those continuing background HF therapy without empagliflozin to evaluate the effects of empagliflozin.
Participants:
- Were randomly assigned to receive empagliflozin plus background HF pharmacotherapy or background HF pharmacotherapy therapy without empagliflozin
- Underwent sleep studies, transthoracic echocardiography and clinical assessments at baseline, 3 months, and 6 months.
- Provided blood samples for measurement of cardiac biomarkers and oxidative stress markers.
- Completed standardized questionnaires assessing sleep quality and symptoms.
- Initiated CPAP therapy after 3 months and continued treatment until the end of the study.
Detailed description
Heart failure and obstructive sleep apnea frequently coexist and are linked through complex pathophysiological mechanisms, including intermittent hypoxemia, sympathetic activation, oxidative stress, and hemodynamic alterations. This bidirectional interaction contributes to disease progression, impaired quality of life, and adverse clinical outcomes. While CPAP remains the standard treatment for OSA, treatment response in patients with coexisting HF is variable, and additional therapeutic strategies targeting both conditions are of clinical interest.
Sodium-glucose cotransporter-2 inhibitors, including empagliflozin, have demonstrated significant cardiovascular benefits in patients with HF. Their mechanisms of action, including osmotic diuresis, reduction in intravascular and interstitial fluid volume, and improvement in cardiac function, may also influence the pathophysiology of OSA, particularly by reducing nocturnal rostral fluid shift and upper airway collapsibility. However, prospective randomized data evaluating the effects of SGLT2i on sleep-disordered breathing in patients with HF and OSA remain limited.
This randomized controlled clinical trial was designed to evaluate the effects of empagliflozin on sleep, cardiac, and biochemical outcomes in adults with coexisting HF and OSA, and to assess the impact of subsequent CPAP therapy. The study incorporated a sequential two-phase design to allow differentiation between the early effects of pharmacological therapy and the later effects of CPAP.
In the first phase (0-3 months), participants were randomly assigned in a 1:1 ratio to receive empagliflozin in addition to background HF therapy or to continue background HF therapy without empagliflozin. This phase was designed to evaluate the isolated effect of empagliflozin on OSA severity, nocturnal oxygenation, cardiac function, and oxidative stress.
In the second phase (3-6 months), CPAP therapy was initiated in all participants, while empagliflozin treatment was continued in the study group. This phase was designed to assess the effect of CPAP therapy in both groups and to explore whether prior exposure to empagliflozin influenced the response to CPAP.
Assessments were performed at baseline, 3 months, and 6 months. Sleep-related outcomes included apnea-hypopnea index (AHI), mean oxygen saturation (MOS), lowest oxygen saturation (LOS), and time spent with oxygen saturation below 90% (T<90%), obtained from type III sleep studies. Cardiac outcomes included left ventricular ejection fraction assessed by transthoracic echocardiography and N-terminal pro-B-type natriuretic peptide concentrations. Biochemical analyses included evaluation of oxidative stress markers, including TOS, TAS, and OSI. Patient-reported outcomes included validated questionnaires assessing sleep quality, daytime sleepiness, and quality of life.
The study also included exploratory analyses to assess relationships between sleep-related and cardiac parameters, as well as to evaluate whether baseline OSA severity influenced response to treatment. The sequential design of the study allowed assessment of phase-specific effects and potential interaction between pharmacological therapy and CPAP.
Overall, the study aimed to provide a comprehensive evaluation of the role of empagliflozin as an adjunctive therapy in patients with HF and OSA, and to clarify its potential impact on sleep-disordered breathing, cardiac function, and oxidative stress in the context of subsequent CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial with a sequential two-phase design. Participants were randomized 1:1 to receive empagliflozin in addition to background heart failure therapy or to continue background therapy without empagliflozin. During the first phase (0-3 months), the effect of empagliflozin was assessed. During the second phase (3-6 months), continuous positive airway pressure (CPAP) therapy was initiated in all participants, while empagliflozin was continued in the intervention group, allowing evaluation of CPAP effects and the influence of prior empagliflozin exposure on treatment response. The sequential design allowed separation of early pharmacological effects from later CPAP-driven improvements and enabled assessment of whether prior SGLT2 inhibition modifies subsequent response to CPAP therapy.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin + Background Heart Failure Therapy | Experimental | Drug: Empagliflozin, Device: Continuous Positive Airway Pressure (CPAP)Participants with HF and OSA initiated empagliflozin at baseline in addition to background heart failure therapy and continued treatment throughout the 6-month study period. During the first phase (0-3 months), the effects of empagliflozin were assessed. Continuous positive airway pressure therapy was initiated after 3 months and continued until the end of the study. This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy. |
| Background Heart Failure Therapy Without Empagliflozin | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)Participants continued background heart failure therapy without empagliflozin. Continuous positive airway pressure (CPAP) therapy was initiated after 3 months and continued until the end of the study. This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Diagnosed heart failure (HF) on stable guideline-directed medical therapy
- Obstructive sleep apnea (OSA) confirmed by sleep study (mild, moderate, or severe)
- No prior treatment with empagliflozin or other sodium-glucose cotransporter-2 inhibitors
- No prior treatment with continuous positive airway pressure therapy
Key exclusion criteria (9 listed)
- Age <18 years
- Body mass index (BMI) ≥40 kg/m²
- Active malignancy
- Severe renal impairment (estimated glomerular filtration rate <25 mL/min/1.73 m²)
- Advanced hepatic insufficiency
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 |
|---|---|---|
| EmpagliflozinEmpagliflozin was initiated at baseline at a dose of 10 mg once daily, administered orally, in addition to background heart failure therapy, and continued throughout the 6-month study period. | Drug | Empagliflozin + Background Heart Failure Therapy |
| Continuous Positive Airway Pressure (CPAP)Continuous positive airway pressure therapy was initiated after 3 months in all participants using standard clinical practice. CPAP was applied nightly during sleep, with pressure settings individually titrated. The mean therapeutic pressure was approximately 15.5 ± 2.5 cm H₂O. Treatment was continued until the end of the study. | Device | Background Heart Failure Therapy Without Empagliflozin, Empagliflozin + Background Heart Failure Therapy |
Primary outcome
Change in Apnea-Hypopnea Index (AHI).
Time frame: Baseline, 3 months, and 6 months.
Change in AHI, measured as the number of apnea and hypopnea events per hour of sleep, assessed between baseline and follow-up visits at 3 and 6 months.
1 secondary outcome
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations.
Time frame: Baseline, 3 months, and 6 months.
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. It is not yet determined whether individual participant data will be made available. Data sharing plans will be considered after completion of primary and secondary analyses and publication of study results, in accordance with institutional policies and applicable regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin and Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea (OSA) and Sleep Apnea Syndrome, Obstructive, run by Medical University of Bialystok at 1 site in Poland.
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 8 inclusion and 9 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 29 Apr 2026. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Apnea-Hypopnea Index (AHI). (time frame: Baseline, 3 months, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.