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A blood test for liver trouble may flag hidden risk in sleep apnea patients

NCT ID NCT07798518

Knowledge-focused Sponsor: Hisar Intercontinental Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

Researchers are looking at whether the FIB-4 index, a blood-based score that estimates liver fibrosis risk, tracks with the severity of obstructive sleep apnea (OSA) and low oxygen levels during sleep. They will review records from 373 adults who had full-night sleep studies, grouping them by apnea severity and comparing their FIB-4 values. The study also checks how many people with OSA have FIB-4 scores above a common threshold that suggests further liver evaluation. This is an observational analysis, so it can point to connections but cannot prove that sleep apnea causes liver changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If a link exists, FIB-4 could become a simple blood-based clue for spotting liver fibrosis risk in people with sleep apnea, prompting earlier liver checks.
What could go wrong
This is a retrospective review, so it can only show associations, not cause and effect. The findings may not apply to everyone, and FIB-4 is not a confirmed liver fibrosis diagnosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

373 people

The number who actually took part.

Started

Jan 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Adults aged 18-65 years. Underwent technically adequate diagnostic full-night polysomnography. Sufficient demographic and clinical data available for OSA classification. Exclusion Criteria: 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. 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.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction-associated steatotic liver disease Obstructive sleep apnea (OSA)

Contacts and locations

Locations

  • Hisar Hospital Intercontinental

    Istanbul, Istanbul, 34768, Turkey (Türkiye)

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