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Recruiting NCT07364929

NCT07364929 Altered Non-Visual Photoreception in Patients With Glaucoma: Impacts on Sleep, Alertness, Mood, and Cognition

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Clinical Trial Summary
NCT ID NCT07364929
Status Recruiting
Phase
Sponsor National University of Singapore
Condition Glaucoma
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2025-09-05
Primary Completion 2026-10

Eligibility & Interventions

Sex All sexes
Min Age 45 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Full-spectrum light exposureStandard indoor light exposure (Control)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 120 participants in total. It began in 2025-09-05 with a primary completion date of 2026-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this study is to understand how light sensitivity in the eye affects sleep, mood, alertness, and cognition in adults with glaucoma compared to healthy individuals aged 45-75 years. The main questions it aims to answer are: 1. Do patients with glaucoma experience poorer sleep, mood, alertness, and cognitive function than age-matched healthy adults? 2. Are these changes related to reduced light sensitivity in special retinal cells called intrinsically photosensitive retinal ganglion cells (ipRGCs), lost in glaucoma? 3. Can exposure to safe, full-spectrum indoor light help improve these functions? Researchers will compare patients with glaucoma and age-matched healthy controls to see if differences in light sensitivity can explain changes in non-visual light responses (i.e., sleep, mood, alertness, and cognition) and whether full-spectrum light exposure can enhance alertness and wellbeing. Participants will: 1. Complete eye exams and baseline questionnaires about their sleep, daytime sleepiness, mood, and wellbeing. 2. Wear a wrist-worn device for 8-16 days to record their sleep patterns and light exposure. 3. Visit the laboratory for cognitive and attention tests following exposure to two lighting conditions (randomized, cross-over): * Standard indoor light (\~300 lux) * Full-spectrum light (\~1000 lux) This study will help researchers understand how glaucoma affects the brain beyond vision and explore whether light-based interventions can improve quality of life for people living with glaucoma.

Eligibility Criteria

Inclusion Criteria: * Patients with glaucoma must meet all of the inclusion criteria to participate in this study. * Patients diagnosed with primary open-angle glaucoma (POAG), as indicated by Humphrey Visual Field (HVF) mean deviation (VFMD) scores better than -12 dB in at least one eye during their most recent clinic visit. * Patients having spared central vision. * Patients aged 45 to 75 years old. * Patients with a best-corrected visual acuity better than 6/12 * English-speaking patients Healthy controls must meet all of the inclusion criteria to participate in this study: * Participants aged 50 to 70 years old. * Participants with a best-corrected visual acuity better than 6/12 * Normal ophthalmic examination * English-speaking participants Exclusion Criteria: * All subjects (patients and controls) meeting any of the exclusion criteria at baseline will be excluded from participation: * Participants with myopia exhibiting a refractive error exceeding -8.00 diopters (D) * Participants with a history of complicated previous intraocular surgery * Participants taking alpha-adrenergic agonist eye drops or other systemic medications or drugs that could affect the pupillary response * Participants with any past or current ocular condition (i.e., age-related retinal diseases (e.g., age-related macular degeneration), retinal pigment epithelium diseases (e.g., Best's disease), diabetic retinopathy, or other optic or generalized neuropathies, significant ocular trauma, or any eye condition affecting fixation (eg. Nystagmus)). * Participants diagnosed with cataracts at NS3+ (Nuclear Sclerosis) and above, as well as those with Posterior Subcapsular (PSC) cataracts * Participants with clinically diagnosed psychiatric or neurologic disorders, including cognitive impairment or dementia * Participants with diagnosed mood disorders * Participants engaged in night shift work within the past three months, are currently using sleeping pills, or have recently travelled across timezones within a month prior to the study * Participants with obstructive sleep apnea * Participants with abnormal auditory function * Participants with impaired color vision * Pre-menopausal women (last menstrual period \< 1 year) (If applicable) * Patients having unilateral glaucoma, congenital glaucoma, non-glaucomatous optic neuropathy, abnormal central vision * Diabetics on treatment

Contact & Investigator

Central Contact

Daniella Mahfoud, MSc.

✉ daniella.mahfoud@u.nus.edu

📞 +65 65165474

Principal Investigator

Raymond P. Najjar, PhD

PRINCIPAL INVESTIGATOR

National University of Singapore

Frequently Asked Questions

Who can join the NCT07364929 clinical trial?

This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07364929 currently recruiting?

Yes, NCT07364929 is actively recruiting participants. Contact the research team at daniella.mahfoud@u.nus.edu for enrollment information.

Where is the NCT07364929 trial being conducted?

This trial is being conducted at Singapore, Singapore, Singapore, Singapore.

Who is sponsoring the NCT07364929 clinical trial?

NCT07364929 is sponsored by National University of Singapore. The principal investigator is Raymond P. Najjar, PhD at National University of Singapore. The trial plans to enroll 120 participants.

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