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Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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.

• 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.

Locations
Other Locations
Poland
Department of Otolaryngology, Medical University of Bialystok
RECRUITING
Bialystok
Contact Information
Primary
Ewa Olszewska, M.D., Prof.
ewa.olszewska@umb.edu.pl
+48 85 831 82 69
Backup
Agnieszka Polecka, M.D.
agnieszka.polecka@umb.edu.pl
+48 85 831 82 69
Time Frame
Start Date: 2025-12-19
Estimated Completion Date: 2029-06-19
Participants
Target number of participants: 120
Treatments
Experimental: Early Positive Airway Pressure (PAP) Therapy
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.
Experimental: Delayed Positive Airway Pressure (PAP) Therapy
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.
No_intervention: Control Group
Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered.
Sponsors
Leads: Medical University of Bialystok
Collaborators: National Science Centre, Poland

This content was sourced from clinicaltrials.gov