NCT07274176

The Effect of Graded Forced Expiration on Intraocular Pressure

The Effect of Graded Forced Expiration on Intraocular Pressure: A Study Using the Airofit Device

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Uşak University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to utilize the Airofit device to systematically measure and characterize the changes in intraocular pressure across its six different levels of forced expiration. This investigation will provide crucial quantitative data on the IOP-respiratory effort relationship, enhancing our understanding of IOP dynamics during controlled respiratory stress and establishing a new, standardized paradigm for such research.

Detailed description

Intraocular pressure (IOP) is a key physiological parameter and the primary modifiable risk factor for glaucoma. Its dynamic nature is well-documented, with fluctuations known to occur due to a variety of factors, including posture, time of day, and bodily maneuvers. The Valsalva maneuver-forced exhalation against a closed glottis-is a classic example of a physiological stressor that can cause a transient, sharp increase in IOP. This occurs due to a rise in intrathoracic and episcleral venous pressure, impeding the outflow of aqueous humor. While the effect of a maximal Valsalva is recognized, the quantitative relationship between graded levels of expiratory force and IOP remains poorly characterized. Previous studies have been limited by the inability to precisely control and measure respiratory effort, often relying on voluntary maneuvers that lack standardization and reproducibility. The recent advent of portable respiratory muscle trainers, such as the Airofit device, offers a novel solution to this methodological challenge. This device enables the precise application of controlled, graded resistance to expiration across multiple predefined levels. Therefore, the primary objective of this study is to utilize the Airofit device to systematically measure and characterize the changes in intraocular pressure across its six different levels of forced expiration. This investigation will provide crucial quantitative data on the IOP-respiratory effort relationship, enhancing our understanding of IOP dynamics during controlled respiratory stress and establishing a new, standardized paradigm for such research. Methods Study Design: A prospective, cross-sectional, single-visit study designed to measure the acute effect of a standardized respiratory exercise session on intraocular pressure (IOP). Participants and Recruitment A convenience sample of 60 adult participants will be recruited from outpatient clinics of physical medicine and rehabilitation of Usak university Participants will be provided with a full information sheet and will sign a written informed consent form prior to any study procedures.

Conditions

• Intraocular Pressure

Interventions

Type	Name	Description
OTHER	Intraocular Pressure after forced expiration	The experiment will entail the acquisition of a total of seven intraocular pressure (IOP) measurements from each subject. * T0: Baseline (pre-intervention, resting). * T1: Immediately after 1 minute of forced expiration at Level 1. * T2: Immediately after 1 minute of forced expiration at Level 2. * T3: Immediately after 1 minute of forced expiration at Level 3. * T4: Immediately after 1 minute of forced expiration at Level 4. * T5: Immediately after 1 minute of forced expiration at Level 5. * T6: Immediately after 1 minute of forced expiration at Level 6.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-02-10
• Completion: 2026-02-25
• First posted: 2025-12-10
• Last updated: 2025-12-22

Locations

1 site across 1 country: Turkey (Türkiye)