Obstructive Sleep Apnea (OSA)FIB-4-OSANCT07798518
FIB-4 Index, Sleep Apnea Severity, and Nocturnal Hypoxemia
An observational study of Obstructive Sleep Apnea (OSA) and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study evaluates whether the Fibrosis-4 (FIB-4) index is associated with the severity of obstructive sleep apnea (OSA) and nighttime oxygen desaturation. Adults who underwent full-night polysomnography were grouped according to apnea-hypopnea index (AHI) as no OSA, mild OSA, moderate OSA, or severe… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 373 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 31 Jul 2026
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18-65 years who underwent diagnostic full-night polysomnography for evaluation of suspected sleep-disordered breathing. Eligible participants were identified retrospectively from hospital records and classified according to the apnea-hypopnea index (AHI) as AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), or severe OSA (≥30 events/hour).
Who may be able to join
- Adults aged 18-65 years.
- Underwent technically adequate diagnostic full-night polysomnography.
- Sufficient demographic and clinical data available for OSA classification.
Who cannot join
- Age <18 or >65 years.
- Technically inadequate polysomnography.
- Split-night or positive airway pressure (PAP) titration studies.
- Known advanced chronic liver disease or cirrhosis.
- Hematologic malignancy.
- Active infection.
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- Clinically significant systemic inflammatory or autoimmune disease.
- Chemotherapy, radiotherapy, or immunosuppressive therapy.
- Pregnancy.
- Clinically significant alcohol use or alcohol-related liver disease.
- Missing laboratory components required for the relevant FIB-4 or NLR analysis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Hospital Intercontinental
Istanbul, Istanbul, 34768
About this study
Official title: Association of the FIB-4 Index With Obstructive Sleep Apnea Severity and Nocturnal Hypoxemia: A Retrospective Polysomnographic Study
This retrospective study evaluates whether the Fibrosis-4 (FIB-4) index is associated with the severity of obstructive sleep apnea (OSA) and nighttime oxygen desaturation. Adults who underwent full-night polysomnography were grouped according to apnea-hypopnea index (AHI) as no OSA, mild OSA, moderate OSA, or severe OSA. Routine clinical, laboratory, and sleep-study data were reviewed.
The main aim is to compare FIB-4 values across OSA severity groups and to examine whether FIB-4 is related to AHI, oxygen desaturation index (ODI), and minimum oxygen saturation during sleep. The study also evaluates the proportion of patients with FIB-4 values at or above 1.30, a commonly used threshold for identifying individuals who may need further liver fibrosis assessment.
FIB-4 is used in this study as a noninvasive liver fibrosis risk marker and not as a diagnosis of liver fibrosis.
Read the detailed description
This is a single-center, retrospective observational study of adults aged 18-65 years who underwent diagnostic full-night polysomnography. Participants were classified according to the apnea-hypopnea index (AHI) as AHI <5 events/h, mild OSA (5-14.9 events/h), moderate OSA (15-29.9 events/h), or severe OSA (≥30 events/h).
Demographic, polysomnographic, hematologic, and biochemical data were obtained retrospectively from hospital records. Laboratory measurements closest to the polysomnography date within ±30 days were used. The FIB-4 index was calculated from age, aspartate aminotransferase, alanine aminotransferase, and platelet count.
FIB-4 was evaluated as a continuous variable and using clinically established risk thresholds. Associations between FIB-4 and polysomnographic measures, including AHI, oxygen desaturation index (ODI), and minimum peripheral oxygen saturation (SpO₂), were examined. The study also explored the relationship between FIB-4 and the neutrophil-to-lymphocyte ratio (NLR). No study-related intervention was administered.
- Keywords
- Obstructive Sleep Apnea, Nocturnal Hypoxemia, Oxygen Desaturation Index, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AHI <5 (Non-OSA) | Participants with an apnea-hypopnea index (AHI) <5 events/hour on full-night polysomnography. | |
| Mild OSA | Participants with AHI 5-14.9 events/hour. | |
| Moderate OSA | Participants with AHI 15-29.9 events/hour. | |
| Severe OSA | Participants with AHI ≥30 events/hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
FIB-4 index was compared across four groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour).
Measured: Within 30 days before or after polysomnography
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
FIB-4 index will be compared across four OSA severity groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour). FIB-4 is calculated as age (years) × AST (U/L) / [platelet count (10⁹/L) × √ALT (U/L)].
Measured: Within ±30 days of polysomnography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Jan 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekir Sami Uyanık, Hisar Intercontinental Hospital
- Investigators
- Bekir Sami Uyanık, MD,, Principal investigator, Hisar Hospital IntercontinentalOrhan Dalkılıç, MD, Principal investigator, Hisar Hospital IntercontinentalSüleyman Hilmi İpekçi, MD, Principal investigator, Hisar Hospital Intercontinental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798518
- Sponsor's protocol ID
- 26-76
- Acronym
- FIB-4-OSA
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be publicly shared because the study is based on retrospective hospital records containing potentially sensitive clinical information. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
Publications
Bettini S, Serra R, Fabris R, Dal Pra C, Favaretto F, Dassie F, Duso C, Vettor R, Busetto L. Association of obstructive sleep apnea with non-alcoholic fatty liver disease in patients with obesity: an observational study. Eat Weight Disord. 2022 Feb;27(1):335-343. doi: 10.1007/s40519-021-01182-9. Epub 2021 Apr 3.
PubMed 33811619Gul S, Ozyurt S, Keklikkiran C, Gumus A. The Relationship Between Chronic Intermittent Hypoxia and MASLD and Fibrosis in Obstructive Sleep Apnea Patients. J Clin Med. 2026 Mar 3;15(5):1911. doi: 10.3390/jcm15051911.
PubMed 41827328Trzepizur W, Boursier J, Poilane J, Bureau C, Sedkaoui K, Pontier S, Costentin C, Pepin JL, Schnee M, Bizieux A, Guillaume M, Hamel JF, Gagnadoux F. Association between obstructive sleep apnea and liver fibrosis in patients with suspected nonalcoholic fatty liver disease. Sleep. 2026 Feb 10;49(2):zsaf265. doi: 10.1093/sleep/zsaf265.
PubMed 40884485Mesarwi OA, Loomba R, Malhotra A. Obstructive Sleep Apnea, Hypoxia, and Nonalcoholic Fatty Liver Disease. Am J Respir Crit Care Med. 2019 Apr 1;199(7):830-841. doi: 10.1164/rccm.201806-1109TR.
PubMed 30422676
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the FIB-4 Index With Obstructive Sleep Apnea Severity and Nocturnal Hypoxemia: A Retrospective Polysomnographic Study
- ClinicalTrials.gov ID
- NCT07798518
- Acronym / sponsor ID
- FIB-4-OSA / 26-76
- Keywords
- Obstructive Sleep Apnea, Nocturnal Hypoxemia, Oxygen Desaturation Index, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 1 Sep 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.
This retrospective study evaluates whether the Fibrosis-4 (FIB-4) index is associated with the severity of obstructive sleep apnea (OSA) and nighttime oxygen desaturation. Adults who underwent full-night polysomnography were grouped according to apnea-hypopnea index (AHI) as no OSA, mild OSA, moderate OSA, or severe OSA. Routine clinical, laboratory, and sleep-study data were reviewed.
The main aim is to compare FIB-4 values across OSA severity groups and to examine whether FIB-4 is related to AHI, oxygen desaturation index (ODI), and minimum oxygen saturation during sleep. The study also evaluates the proportion of patients with FIB-4 values at or above 1.30, a commonly used threshold for identifying individuals who may need further liver fibrosis assessment.
FIB-4 is used in this study as a noninvasive liver fibrosis risk marker and not as a diagnosis of liver fibrosis.
Detailed description
This is a single-center, retrospective observational study of adults aged 18-65 years who underwent diagnostic full-night polysomnography. Participants were classified according to the apnea-hypopnea index (AHI) as AHI <5 events/h, mild OSA (5-14.9 events/h), moderate OSA (15-29.9 events/h), or severe OSA (≥30 events/h).
Demographic, polysomnographic, hematologic, and biochemical data were obtained retrospectively from hospital records. Laboratory measurements closest to the polysomnography date within ±30 days were used. The FIB-4 index was calculated from age, aspartate aminotransferase, alanine aminotransferase, and platelet count.
FIB-4 was evaluated as a continuous variable and using clinically established risk thresholds. Associations between FIB-4 and polysomnographic measures, including AHI, oxygen desaturation index (ODI), and minimum peripheral oxygen saturation (SpO₂), were examined. The study also explored the relationship between FIB-4 and the neutrophil-to-lymphocyte ratio (NLR). No study-related intervention was administered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AHI <5 (Non-OSA) | – | –Participants with an apnea-hypopnea index (AHI) <5 events/hour on full-night polysomnography. |
| Mild OSA | – | –Participants with AHI 5-14.9 events/hour. |
| Moderate OSA | – | –Participants with AHI 15-29.9 events/hour. |
| Severe OSA | – | –Participants with AHI ≥30 events/hour. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18-65 years who underwent diagnostic full-night polysomnography for evaluation of suspected sleep-disordered breathing. Eligible participants were identified retrospectively from hospital records and classified according to the apnea-hypopnea index (AHI) as AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), or severe OSA (≥30 events/hour).
Key inclusion criteria (3 listed)
- Adults aged 18-65 years.
- Underwent technically adequate diagnostic full-night polysomnography.
- Sufficient demographic and clinical data available for OSA classification.
Key exclusion criteria (11 listed)
- Age <18 or >65 years.
- Technically inadequate polysomnography.
- Split-night or positive airway pressure (PAP) titration studies.
- Known advanced chronic liver disease or cirrhosis.
- Hematologic malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
Time frame: Within 30 days before or after polysomnography
FIB-4 index was compared across four groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour).
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
Time frame: Within ±30 days of polysomnography
FIB-4 index will be compared across four OSA severity groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour). FIB-4 is calculated as age (years) × AST (U/L) / [platelet count (10⁹/L) × √ALT (U/L)].
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 18 Sep 2026.
- Results publication: PubMed 33811619Bettini S, Serra R, Fabris R, Dal Pra C, Favaretto F, Dassie F, Duso C, Vettor R, Busetto L. Association of obstructive sleep apnea with non-alcoholic fatty liver disease in patients with obesity: an observational study. Eat Weight Disord. 2022 Feb;27(1):335-343. doi: 10.1007/s40519-021-01182-9. Epub 2021 Apr 3.
- Results publication: PubMed 41827328Gul S, Ozyurt S, Keklikkiran C, Gumus A. The Relationship Between Chronic Intermittent Hypoxia and MASLD and Fibrosis in Obstructive Sleep Apnea Patients. J Clin Med. 2026 Mar 3;15(5):1911. doi: 10.3390/jcm15051911.
- Results publication: PubMed 40884485Trzepizur W, Boursier J, Poilane J, Bureau C, Sedkaoui K, Pontier S, Costentin C, Pepin JL, Schnee M, Bizieux A, Guillaume M, Hamel JF, Gagnadoux F. Association between obstructive sleep apnea and liver fibrosis in patients with suspected nonalcoholic fatty liver disease. Sleep. 2026 Feb 10;49(2):zsaf265. doi: 10.1093/sleep/zsaf265.
- Results publication: PubMed 30422676Mesarwi OA, Loomba R, Malhotra A. Obstructive Sleep Apnea, Hypoxia, and Nonalcoholic Fatty Liver Disease. Am J Respir Crit Care Med. 2019 Apr 1;199(7):830-841. doi: 10.1164/rccm.201806-1109TR.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be publicly shared because the study is based on retrospective hospital records containing potentially sensitive clinical information. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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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.
Bekir Sami Uyanık, MD, principal investigator
Hisar Hospital Intercontinental
Orhan Dalkılıç, MD principal investigator
Hisar Hospital Intercontinental
Süleyman Hilmi İpekçi, MD principal investigator
Hisar Hospital Intercontinental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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 18 Sep 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 Turkey (Türkiye). 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?
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups (time frame: Within 30 days before or after polysomnography). 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 NCT07798518, which also lists 4 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 18 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.