Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06023927 |
| Other study ID # |
21-0958-MEETH |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2024 |
| Est. completion date |
June 14, 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Northwell Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this research study is to learn more about the relationship between
Obstructive Sleep Apnea (OSA) and Normal Tension Glaucoma (NTG). OSA is a nighttime disorder
of the upper airway that causes an intermittent lack of oxygen while sleeping. NTG is a type
of glaucoma that occurs despite the normal intraocular pressure levels, making its detection
more difficult. Left untreated, irreversible optic nerve damage and extensive vision loss can
result. Previous research has shown some evidence between OSA and the development of NTG. The
investigators are researching whether undergoing treatment for OSA would help to improve the
vascular health to the retina, and in effect, improve the early signs of visual dysfunction
seen with diagnostic testing.
Description:
Glaucoma is a leading cause of irreversible blindness worldwide. Normal tension glaucoma
(NTG) is a challenging subtype in which progressive changes to the optic nerve and retinal
ganglion cell (RGC) function occur despite normal intraocular pressures (IOP). In most types
of glaucoma, elevated IOP is the major risk factor and a key target for medical therapy. The
absence of IOP elevation in NTG poses diagnostic dilemmas and therapeutic challenges. The
disease is often diagnosed late, with irreversible atrophic changes to the optic nerve and
permanent loss of vision. These clinically manifested structural and functional changes seen
on optical coherence tomography (OCT) and visual field (VF) tests are likely preceded by a
subclinical stage at which RGCs become increasingly dysfunctional before dying.
Obstructive sleep apnea (OSA) is characterized by intermittent nocturnal upper airway
collapse, leading to oxygen deprivation and hypoxemia. It is a common cause of daytime
sleepiness and is associated with an increased likelihood of hypertension, cardiovascular
disease, stroke, and diminished quality of life. Continuous Positive Airway Pressure (CPAP)
therapy is an established treatment for moderate to severe OSA in which patients sleep with a
special mask that helps to regulate inspiratory and expiratory flow, alleviating hypoxia.
The investigators hypothesize that eliminating the hypoxia induced by OSA could have a
favorable effect on retinal blood flow, thereby reducing the likelihood of progressive RGC
damage and dysfunction in subjects at risk for NTG. The investigators are proposing a
prospective, longitudinal, non-randomized study to evaluate the role of innovative diagnostic
technologies in the early detection of NTG, and to establish its association with OSA.
Additionally, the investigators will monitor the effects of OSA treatment in preventing the
development of the disease, or at least halting its progression. Special attention will be
given to the sex differences in the analysis to recognize the substantial differences in OSA
between men and women, as well as the prevalence of NTG in different OSA severity groups.
While under the care of a Sleep Medicine physician, newly diagnosed subjects with OSA
interested in participating will be recruited from the Northwell sleep center. Prior to
initiating continuous positive airway pressure therapy (CPAP), consented participants will be
screened to satisfying the eligibility criteria, and undergo a complete ophthalmological
exam. Functional and structural diagnostic testing will be performed to evaluate baseline
measures, including visual field testing, OCT, pattern electroretinography (PERG) and optical
coherence tomography-angiography (OCTA) testing. Using the American Association of sleep
Medicine (AASM) criteria, 3 groups will be formed based on the apnea-hypopnea index (AHI).
The severity of OSA is graded as mild (AHI<15), moderate (1530). The
Epworth questionnaire will be used as part of routine clinical care to monitor improvement or
deterioration after treatment. Once the baseline ophthalmological exam has been performed,
subjects will return to the sleep center to begin CPAP therapy for OSA. Three follow up
ophthalmic exams will be performed at 3, 6, and 9 months after initiating CPA therapy.
