Obstructive Sleep ApneaNCT07723144
Identification of Biomarkers of Obstructive Sleep Apnea.
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea and Obstructive Sleep Apnea (OSA), run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Obstructive sleep apnea (OSA) is a common sleep disorder associated with intermittent hypoxia, systemic inflammation, oxidative stress, and an increased risk of cardiovascular and metabolic diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA), Obstructive Sleep Apnea (OSAS)
- What is being tested?
- Positive Airway Pressure (PAP) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 19 Dec 2025to 19 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with obstructive sleep apnea (OSA):
- Age 18 to 65 years.
- Moderate or severe obstructive sleep apnea confirmed by overnight polysomnography (apnea-hypopnea index [AHI] ≥15 events/hour).
- Willing and able to provide written informed consent.
- Willing to undergo repeated blood sampling and study assessments.
- Willing to use positive airway pressure (PAP) therapy and accept random assignment to immediate or delayed treatment.
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- Control participants:
- Age 18 to 65 years.
- No obstructive sleep apnea (AHI <5 events/hour on overnight polysomnography).
- Willing and able to provide written informed consent.
- Willing to undergo study assessments and blood sampling.
Who cannot join
- Mild obstructive sleep apnea (AHI 5 to <15 events/hour).
- Central sleep apnea.
- Previous treatment for obstructive sleep apnea within the previous 3 months.
- Body mass index (BMI) ≥40 kg/m².
- Severe cardiovascular disease.
- Severe kidney disease or impaired renal function.
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- Significant liver disease.
- Chronic inflammatory, autoimmune, or rheumatic disease.
- Active cancer or other condition associated with systemic inflammation.
- Chronic respiratory diseases, including asthma or chronic obstructive pulmonary disease.
- Respiratory infection within 4 weeks before enrollment.
- Major surgery or significant injury within the previous 3 months.
- Chronic rhinosinusitis.
- Current treatment with systemic corticosteroids, immunosuppressive drugs, cytotoxic drugs, chronic anti-inflammatory medications, or other medications that may influence inflammatory biomarkers.
- Pregnancy or any condition that, in the opinion of the investigators, would make participation unsafe or interfere with interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
Ewa Olszewska, M.D., Prof., +48 85 831 82 69, ewa.olszewska@umb.edu.pl
Agnieszka Polecka, M.D., +48 85 831 82 69, agnieszka.polecka@umb.edu.pl
About this study
Official title: Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.
Obstructive sleep apnea (OSA) is a common sleep disorder associated with intermittent hypoxia, systemic inflammation, oxidative stress, and an increased risk of cardiovascular and metabolic diseases. Current diagnostic methods are effective but have limited availability and do not adequately predict disease burden or treatment response.
The purpose of this study is to identify and validate blood biomarkers that may improve the screening, diagnosis, risk stratification, and monitoring of adults with OSA. A total of 120 participants will undergo clinical evaluation and overnight polysomnography. Participants with moderate-to-severe OSA will be randomly assigned to either immediate or delayed positive airway pressure (PAP) therapy, while participants without OSA will serve as controls. Blood samples will be collected at predefined time points and analyzed for inflammatory, metabolic, oxidative stress, and other candidate biomarkers.
The study aims to determine which biomarkers are associated with OSA severity and how they change in response to PAP therapy. The results may contribute to the development of more accessible and personalized diagnostic and monitoring strategies for patients with OSA.
Read the detailed description
Obstructive sleep apnea (OSA) is a highly prevalent disorder characterized by recurrent upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, oxidative stress, systemic inflammation, endothelial dysfunction, and metabolic disturbances. Untreated OSA is associated with an increased risk of cardiovascular disease, diabetes mellitus, stroke, impaired quality of life, and all-cause mortality. Despite the availability of polysomnography as the reference diagnostic method, current diagnostic approaches have limited accessibility and do not adequately reflect disease burden or predict treatment response.
The primary objective of this study is to identify and validate blood biomarkers associated with the presence, severity, and treatment response of OSA. The investigators hypothesize that selected circulating proteins, inflammatory mediators, oxidative stress markers, and metabolic profiles can improve the screening, diagnosis, risk stratification, and monitoring of patients with OSA.
A total of 120 adults will undergo standardized clinical evaluation and overnight polysomnography. Participants diagnosed with moderate-to-severe OSA will be randomly assigned to either immediate or delayed initiation of positive airway pressure (PAP) therapy, whereas participants without OSA will serve as the control group. Blood samples will be collected at predefined study visits to evaluate changes in candidate biomarkers before and during treatment.
The study will investigate a broad panel of biomarkers representing inflammatory pathways, endothelial dysfunction, oxidative stress, and metabolomic alterations using validated laboratory techniques, including multiplex immunoassays, enzyme-linked immunosorbent assays (ELISA), and metabolomic analyses. Changes in biomarker profiles will be evaluated in relation to OSA severity and response to PAP therapy.
The results of this study are expected to improve the understanding of the biological mechanisms underlying OSA and facilitate the development of novel biomarker-based approaches for screening, diagnosis, disease monitoring, and personalized management of patients with obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA), Obstructive Sleep Apnea (OSAS), Obstructive Sleep Apnea (SAOS), Obstructive Sleep Apnea (Moderate to Severe)
- Being tested
- Positive Airway Pressure (PAP) Therapy
- Keywords
- Obstructive sleep apnea, OSA, Positive airway pressure therapy, CPAP, Blood biomarkers, Polysomnography, Inflammation, Oxidative stress, Metabolomics, Precision medicine
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure (PAP) TherapyDevice
Positive airway pressure (PAP) therapy will be administered according to current clinical practice guidelines for the treatment of obstructive sleep apnea. PAP settings will be individually titrated based on clinical assessment and sleep study findings to ensure effective treatment. Participants assigned to PAP therapy will use the device during sleep for the duration specified in the study protocol. Adherence to therapy will be monitored using device-recorded usage data.
| Study group | Role | What they receive |
|---|---|---|
| Early Positive Airway Pressure (PAP) Therapy | Experimental | Participants with moderate-to-severe obstructive sleep apnea receive positive airway pressure (PAP) therapy immediately after randomization and continue treatment for 6 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months. Receives: Device: Positive Airway Pressure (PAP) Therapy |
| Delayed Positive Airway Pressure (PAP) Therapy | Experimental | Participants with moderate-to-severe obstructive sleep apnea do not receive PAP therapy during the first 3 months after randomization. PAP therapy is initiated after the 3-month evaluation and continued for the following 3 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months. Receives: Device: Positive Airway Pressure (PAP) Therapy |
| Control Group | No intervention | Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline
Comparison of baseline serum and plasma concentrations of a predefined panel of circulating protein biomarkers (osteoprotegerin, cardiotrophin-1, chitinase-3-like protein 1/YKL-40, CRP, HbA1c, erythropoietin, thioredoxin, PD-L1) and a predefined multiplex panel of 48 cytokines, chemokines and growth factors, measured by ELISA and multiplex ELISA (Luminex), between adults with moderate-to-severe OSA (AHI >=15) and non-OSA controls (AHI <5) defined by polysomnography. Results will be reported in assay-appropriate units, including pg/mL, ng/mL, mg/L, or percentage, as applicable.
Measured: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
Change in blood biomarker concentrations in OSA participants after positive airway pressure (PAP) therapy.
Change from baseline in serum and plasma concentrations of the predefined biomarker panel after positive airway pressure (PAP) therapy. In the Early Treatment Group change is assessed after 3 and 6 months of continuous PAP; in the Delay-TG after 3 months of PAP delivered between months 3 and 6. Aim: determine whether and to what degree biomarker values change in response to standard OSA treatment.
Measured: Baseline, 3 months and 6 months.
Secondary outcomes (5)
Correlation between baseline blood biomarker concentrations and OSA severity (AHI)
Correlation between baseline concentrations of the studied blood biomarkers and OSA severity expressed by the apnea-hypopnea index (AHI), as well as mean and lowest nocturnal oxygen saturation, in OSA participants. Goal: evaluate suitability of biomarkers for grading OSA severity.
Measured: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
Normalization of blood biomarker concentrations toward control values after PAP therapy in OSA participants.
Comparison of post-PAP-treatment biomarker concentrations in OSA participants (Early-TG and Delay-TG) with the enrollment values of the non-OSA control group, to assess whether treatment shifts biomarker values toward those of healthy controls. Goal: identify biomarkers specific to OSA-related hypoxia that approach the concentrations observed in participants without OSA.
Measured: Control: baseline; Early-TG: Month 3 and Month 6; Delay-TG: Month 6.
Effect of PAP treatment duration (3 vs 6 months) on blood biomarker concentrations
Assessment of the impact of PAP treatment duration on biomarker values: (a) comparison of post-treatment values between the Early Treatment Group (6 months of PAP) and the Delay Treatment Group (3 months of PAP); (b) within Early-TG, comparison of values after 3 versus 6 months to evaluate whether changes become more robust with continued treatment. Goal: determine whether longer therapy produces greater biomarker change.
Measured: 3 months and 6 months
Stability of blood biomarker concentrations in untreated OSA (3-month observation period).
Comparison of biomarker concentrations in the Delay-TG between baseline and after the 3-month observation period without any treatment, to verify that biomarker values do not change spontaneously in the absence of PAP therapy. Serves as the internal untreated reference for the treatment effect.
Measured: Baseline and 3 months (Delay-TG)
Differences in serum and plasma metabolomic profiles between OSA and controls and in response to PAP therapy.
Targeted and untargeted metabolomic profiling (GC-MS and LC-QTOF-MS; amino acids, carbohydrates, fatty acids, and specific lipids including phosphatidylcholines, ceramides, triglycerides and lysophosphatidylcholines) compared between OSA participants and controls at baseline, and before versus after PAP therapy in OSA participants. Goal: identify known and novel metabolite biomarkers of OSA.
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 posted23 Jul 2026
- Study start19 Dec 2025
- Primary completion19 Jun 2029 (estimated)
- Study completion19 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723144
- Sponsor's protocol ID
- 2024/55/B/NZ7/00418
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data sharing plan has not yet been determined. A final decision will be made after study completion in accordance with institutional policies, ethical approvals, and applicable regulations.
Publications
Olszewska E, Pietrewicz TM, Swiderska M, Jamiolkowski J, Chabowski A. A Case-Control Study on the Changes in High-Sensitivity C-Reactive Protein and Tumor Necrosis Factor-Alpha Levels with Surgical Treatment of OSAS. Int J Mol Sci. 2022 Nov 15;23(22):14116. doi: 10.3390/ijms232214116.
PubMed 36430593Mohit, Tomar MS, Araniti F, Pateriya A, Singh Kushwaha RA, Singh BP, Jurel SK, Singh RD, Shrivastava A, Chand P. Identification of metabolic fingerprints in severe obstructive sleep apnea using gas chromatography-Mass spectrometry. Front Mol Biosci. 2022 Nov 21;9:1026848. doi: 10.3389/fmolb.2022.1026848. eCollection 2022.
PubMed 36504723Kheirandish-Gozal L, Gozal D. Obstructive Sleep Apnea and Inflammation: Proof of Concept Based on Two Illustrative Cytokines. Int J Mol Sci. 2019 Jan 22;20(3):459. doi: 10.3390/ijms20030459.
PubMed 30678164Olszewska E, De Vito A, Heiser C, Vanderveken O, O'Connor-Reina C, Baptista P, Kotecha B, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 3 Palatal Surgery, Outcomes and Follow-Up, Complications, and Post-Operative Management. J Clin Med. 2024 Sep 13;13(18):5438. doi: 10.3390/jcm13185438.
PubMed 39336926Olszewska E, De Vito A, O'Connor-Reina C, Heiser C, Baptista P, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 2 Decision-Making in Surgical Management and Peri-Operative Considerations. J Clin Med. 2024 Apr 3;13(7):2083. doi: 10.3390/jcm13072083.
PubMed 38610848Olszewska E, De Vito A, Baptista P, Heiser C, O'Connor-Reina C, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 1 Definitions and Diagnosis. J Clin Med. 2024 Jan 16;13(2):502. doi: 10.3390/jcm13020502.
PubMed 38256636Olszewska E, Woodson BT. Palatal anatomy for sleep apnea surgery. Laryngoscope Investig Otolaryngol. 2019 Jan 10;4(1):181-187. doi: 10.1002/lio2.238. eCollection 2019 Feb.
PubMed 30828637Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
PubMed 31300334Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PubMed 23589584Olszewska, E., Chrapanie i Bezdechy. Diagnostyka i Leczenie [Snoring and Apnea. Diagnosis and Treatment] 2019, Warszawa: Medipage
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT07723144
- Acronym / sponsor ID
- 2024/55/B/NZ7/00418
- Conditions
- Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA), Obstructive Sleep Apnea (OSAS), Obstructive Sleep Apnea (SAOS), Obstructive Sleep Apnea (Moderate to Severe)
- Keywords
- Obstructive sleep apnea, OSA, Positive airway pressure therapy, CPAP, Blood biomarkers, Polysomnography, Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 19 Jun 2029 (estimated)
- Study completion
- 19 Jun 2029 (estimated)
- First posted
- 23 Jul 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.
Obstructive sleep apnea (OSA) is a common sleep disorder associated with intermittent hypoxia, systemic inflammation, oxidative stress, and an increased risk of cardiovascular and metabolic diseases. Current diagnostic methods are effective but have limited availability and do not adequately predict disease burden or treatment response.
The purpose of this study is to identify and validate blood biomarkers that may improve the screening, diagnosis, risk stratification, and monitoring of adults with OSA. A total of 120 participants will undergo clinical evaluation and overnight polysomnography. Participants with moderate-to-severe OSA will be randomly assigned to either immediate or delayed positive airway pressure (PAP) therapy, while participants without OSA will serve as controls. Blood samples will be collected at predefined time points and analyzed for inflammatory, metabolic, oxidative stress, and other candidate biomarkers.
The study aims to determine which biomarkers are associated with OSA severity and how they change in response to PAP therapy. The results may contribute to the development of more accessible and personalized diagnostic and monitoring strategies for patients with OSA.
Detailed description
Obstructive sleep apnea (OSA) is a highly prevalent disorder characterized by recurrent upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, oxidative stress, systemic inflammation, endothelial dysfunction, and metabolic disturbances. Untreated OSA is associated with an increased risk of cardiovascular disease, diabetes mellitus, stroke, impaired quality of life, and all-cause mortality. Despite the availability of polysomnography as the reference diagnostic method, current diagnostic approaches have limited accessibility and do not adequately reflect disease burden or predict treatment response.
The primary objective of this study is to identify and validate blood biomarkers associated with the presence, severity, and treatment response of OSA. The investigators hypothesize that selected circulating proteins, inflammatory mediators, oxidative stress markers, and metabolic profiles can improve the screening, diagnosis, risk stratification, and monitoring of patients with OSA.
A total of 120 adults will undergo standardized clinical evaluation and overnight polysomnography. Participants diagnosed with moderate-to-severe OSA will be randomly assigned to either immediate or delayed initiation of positive airway pressure (PAP) therapy, whereas participants without OSA will serve as the control group. Blood samples will be collected at predefined study visits to evaluate changes in candidate biomarkers before and during treatment.
The study will investigate a broad panel of biomarkers representing inflammatory pathways, endothelial dysfunction, oxidative stress, and metabolomic alterations using validated laboratory techniques, including multiplex immunoassays, enzyme-linked immunosorbent assays (ELISA), and metabolomic analyses. Changes in biomarker profiles will be evaluated in relation to OSA severity and response to PAP therapy.
The results of this study are expected to improve the understanding of the biological mechanisms underlying OSA and facilitate the development of novel biomarker-based approaches for screening, diagnosis, disease monitoring, and personalized management of patients with obstructive sleep apnea.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Positive Airway Pressure (PAP) Therapy | Experimental | Device: Positive Airway Pressure (PAP) TherapyParticipants with moderate-to-severe obstructive sleep apnea receive positive airway pressure (PAP) therapy immediately after randomization and continue treatment for 6 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months. |
| Delayed Positive Airway Pressure (PAP) Therapy | Experimental | Device: Positive Airway Pressure (PAP) TherapyParticipants with moderate-to-severe obstructive sleep apnea do not receive PAP therapy during the first 3 months after randomization. PAP therapy is initiated after the 3-month evaluation and continued for the following 3 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months. |
| Control Group | No intervention | –Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with obstructive sleep apnea (OSA):
- Control participants:
Key exclusion criteria (15 listed)
- Mild obstructive sleep apnea (AHI 5 to <15 events/hour).
- Central sleep apnea.
- Previous treatment for obstructive sleep apnea within the previous 3 months.
- Body mass index (BMI) ≥40 kg/m².
- Severe cardiovascular 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 |
|---|---|---|
| Positive Airway Pressure (PAP) TherapyPositive airway pressure (PAP) therapy will be administered according to current clinical practice guidelines for the treatment of obstructive sleep apnea. PAP settings will be individually titrated based on clinical assessment and sleep study findings to ensure effective treatment. Participants assigned to PAP therapy will use the device during sleep for the duration specified in the study protocol. Adherence to therapy will be monitored using device-recorded usage data. | Device | Delayed Positive Airway Pressure (PAP) Therapy, Early Positive Airway Pressure (PAP) Therapy |
Primary outcome
Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline
Time frame: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
Comparison of baseline serum and plasma concentrations of a predefined panel of circulating protein biomarkers (osteoprotegerin, cardiotrophin-1, chitinase-3-like protein 1/YKL-40, CRP, HbA1c, erythropoietin, thioredoxin, PD-L1) and a predefined multiplex panel of 48 cytokines, chemokines and growth factors, measured by ELISA and multiplex ELISA (Luminex), between adults with moderate-to-severe OSA (AHI >=15) and non-OSA controls (AHI <5) defined by polysomnography. Results will be reported in assay-appropriate units, including pg/mL, ng/mL, mg/L, or percentage, as applicable.
Change in blood biomarker concentrations in OSA participants after positive airway pressure (PAP) therapy.
Time frame: Baseline, 3 months and 6 months.
Change from baseline in serum and plasma concentrations of the predefined biomarker panel after positive airway pressure (PAP) therapy. In the Early Treatment Group change is assessed after 3 and 6 months of continuous PAP; in the Delay-TG after 3 months of PAP delivered between months 3 and 6. Aim: determine whether and to what degree biomarker values change in response to standard OSA treatment.
5 secondary outcomes
Correlation between baseline blood biomarker concentrations and OSA severity (AHI)
Time frame: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
Normalization of blood biomarker concentrations toward control values after PAP therapy in OSA participants.
Time frame: Control: baseline; Early-TG: Month 3 and Month 6; Delay-TG: Month 6.
Effect of PAP treatment duration (3 vs 6 months) on blood biomarker concentrations
Time frame: 3 months and 6 months
Stability of blood biomarker concentrations in untreated OSA (3-month observation period).
Time frame: Baseline and 3 months (Delay-TG)
Differences in serum and plasma metabolomic profiles between OSA and controls and in response to PAP therapy.
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 36430593Olszewska E, Pietrewicz TM, Swiderska M, Jamiolkowski J, Chabowski A. A Case-Control Study on the Changes in High-Sensitivity C-Reactive Protein and Tumor Necrosis Factor-Alpha Levels with Surgical Treatment of OSAS. Int J Mol Sci. 2022 Nov 15;23(22):14116. doi: 10.3390/ijms232214116.
- Background: PubMed 36504723Mohit, Tomar MS, Araniti F, Pateriya A, Singh Kushwaha RA, Singh BP, Jurel SK, Singh RD, Shrivastava A, Chand P. Identification of metabolic fingerprints in severe obstructive sleep apnea using gas chromatography-Mass spectrometry. Front Mol Biosci. 2022 Nov 21;9:1026848. doi: 10.3389/fmolb.2022.1026848. eCollection 2022.
- Background: PubMed 30678164Kheirandish-Gozal L, Gozal D. Obstructive Sleep Apnea and Inflammation: Proof of Concept Based on Two Illustrative Cytokines. Int J Mol Sci. 2019 Jan 22;20(3):459. doi: 10.3390/ijms20030459.
- Background: PubMed 39336926Olszewska E, De Vito A, Heiser C, Vanderveken O, O'Connor-Reina C, Baptista P, Kotecha B, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 3 Palatal Surgery, Outcomes and Follow-Up, Complications, and Post-Operative Management. J Clin Med. 2024 Sep 13;13(18):5438. doi: 10.3390/jcm13185438.
- Background: PubMed 38610848Olszewska E, De Vito A, O'Connor-Reina C, Heiser C, Baptista P, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 2 Decision-Making in Surgical Management and Peri-Operative Considerations. J Clin Med. 2024 Apr 3;13(7):2083. doi: 10.3390/jcm13072083.
- Background: PubMed 38256636Olszewska E, De Vito A, Baptista P, Heiser C, O'Connor-Reina C, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 1 Definitions and Diagnosis. J Clin Med. 2024 Jan 16;13(2):502. doi: 10.3390/jcm13020502.
- Background: PubMed 30828637Olszewska E, Woodson BT. Palatal anatomy for sleep apnea surgery. Laryngoscope Investig Otolaryngol. 2019 Jan 10;4(1):181-187. doi: 10.1002/lio2.238. eCollection 2019 Feb.
- Background: PubMed 31300334Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
- Background: PubMed 23589584Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- BackgroundOlszewska, E., Chrapanie i Bezdechy. Diagnostyka i Leczenie [Snoring and Apnea. Diagnosis and Treatment] 2019, Warszawa: Medipage
- Individual participant dataSharing planned: Undecided. The individual participant data sharing plan has not yet been determined. A final decision will be made after study completion in accordance with institutional policies, ethical approvals, 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea and Obstructive Sleep Apnea (OSA), 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ewa Olszewska, M.D., Prof. (+48 85 831 82 69, ewa.olszewska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline (time frame: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).). The study lists 2 primary outcomes in all. 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 NCT07723144, which also lists 10 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 23 Jul 2026.