An observational study in Sleep Apnea, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University of Texas Southwestern Medical Center · Observational
This study is a prospective, single center clinical trial to assess corneal sensitivity and nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to participate in the study. After execution and review of the consenting procedures, a detailed history will be taken and a slit lamp examination performed, verifying ocular health. This consists of an examination of both eyes including assessments of ocular lids, lashes, cornea and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope allows for high resolution imaging of the nerve plexus under the corneal epithelium. This corneal nerve plexus is responsible for corneal sensitively and changes or loss have been established as an early, sensitive indicator of corneal neuropathy. The investigators anticipate that this study will require approximately 30 patients for each group and will last approximately 12 months for recruitment and completion of subject visit phases. There is only one clinical visit designed for this project, unscheduled visits may be scheduled in case of an adverse event.
Patient recruitment will be complete at the one-year time point. At the 14 month time point, all data points will have been collected and assessment of the outcome measure (corneal sensitivity in sleep apnea patients versus control patients) will be complete.
Screening Assessment: Following the execution of informed consent, subjects will be carefully screened for ocular signs and symptoms, consistent with the protocol inclusion and exclusion criteria. This includes review of ocular and medical history including use of concomitant \& ocular medications and surgeries performed in the past. Researchers will also collect age, ethnicity, demographics, ophthalmic notes and eye exam history. Upon completion of the screening exam, subjects will be deemed eligible based on study criteria the testing procedures will be performed by the investigators.
Testing procedures: The visit will include:
Slit Lamp Microscopy:
An ocular examination of the external (lids, lashes) along with internal (cornea, lens, retina) structures of the eye can be performed with the aid of a slit lamp. This instruments uses lenses and an external light source that can be refracted at different angles and intensities to assess ocular structures for diagnostic purposes.
Corneal sensitivity measurement:
In Vivo Confocal Microscope
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's enrollment of 130 is above the median of 109 across 659 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Sleep Apnea and normal controls
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Exclusion Criteria:
Corneal Sensitivity
To investigate whether diminished corneal sensitivity contributes to corneal problems commonly reported in patients with sleep apnea. Specifically, this study will correlate changes in corneal touch thresholds with corneal nerve fiber morphology using in vivo confocal microscopy.
Time frame: 1-Day
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2015 to primary completion in Jul 2022, 83 months.
Of 236 non-industry observational studies under Sleep Apnea Syndromes, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 67. This study's 83 months is above that.
Counting every sponsor, half of 264 studies reached it within 35 months; a quarter within 17 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center →