Corneal Sensitivity in Patients With Sleep Apnea Syndrome

NCT02265133 | Completed

• 1 other identifier: STU 102011-033
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  1-Day

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sleep Apnea and normal controls

You may qualify if:

• Healthy, non-smoking volunteers.
• Patients with a diagnosis of sleep apnea.
• Non-contact lens wearers of any gender and race, ages 18 and up.
• Minority representation will be proactively encouraged.
• Patients that are willing to review, understand, and sign the written Informed Consent.
• Written authorization for use or release of health and research study information.
• Patients that are willing and able to cooperate with the Investigator and follow all instructions.

You may not qualify if:

• Use of ocular drops including over the counter (OTC) dry eye drops.
• Previous history of corneal surgery.
• Previous history of ocular trauma.
• History of Diabetes Mellitus.
• Current active or previous history of Herpes virus keratitis.
• Current or former Contact lens wear.
• Chronic history of dry eye disease.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Aston Ambulatory Care Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Danielle Robertson, O.D, PhD

  UTSW Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: October 15, 2014
• Study Start: July 17, 2015
• Primary Completion: July 1, 2022
• Study Completion: August 20, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)