Sleep ApneaNCT02265133
Corneal Sensitivity in Patients With Sleep Apnea Syndrome
An observational study of Sleep Apnea, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jul 2015to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sleep Apnea and normal controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Hospital
Dallas, Texas, 75235
Aston Ambulatory Care Center
Dallas, Texas, 75390
About this study
Official title: Corneal Sensitivity and Nerve Fiber Morphology in Patients With Sleep Apnea Syndrome
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.
Read the detailed description
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:
- Corneal touch sensitivity will be determined using a Cochet-Bonnet aesthesiometer mounted on a standard slit lamp biomicroscope. The Cochet-Bonnet aesthesiometer is routinely used for clinical research purposes to investigate corneal touch thresholds.
- For sensitivity measurements, a 0.12 mm diameter nylon thread will be slowly brought forward to briefly touch the cornea perpendicularly and then quickly withdrawn.
- On each occasion, the patient will be asked to respond whenever a stimulus is felt.
- Thread length is used to quantitatively assess sensitivity. The longest thread length is used first (6 cm), as this provides the lowest stimulus intensity.
- If the subject is unable to detect the touch stimulus, the thread will be systematically shortened in length by 0.5 cm steps until the stimulus is felt.
- The criterion for the sensitivity threshold will be the filament length which gives a 50% positive response from four stimulus applications.
In Vivo Confocal Microscope
- Corneal nerves will be imaged using a modified in vivo confocal microscope which is routinely used in our clinics (HRT Rostock corneal module, Heidelberg Engineering).
- The HRT In Vivo Confocal microscope was modified by adding a motor to automate the focus. This does not alter the integrity, the application, the intent or the light source of the instrument.
- Corneas will be anesthetized with a topical anesthetic, proparacaine, prior to scanning.
- The confocal microscope will briefly touch the patient's eye and the images saved for further analysis.
- Conditions
- Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study start17 Jul 2015
- Primary completion1 Jul 2022
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Robertson, University of Texas Southwestern Medical Center
- Investigators
- Danielle Robertson, O.D, PhD, Principal investigator, UTSW Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265133
- Sponsor's protocol ID
- STU 102011-033
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2011
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Sensitivity and Nerve Fiber Morphology in Patients With Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02265133
- Acronym / sponsor ID
- STU 102011-033
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Corneal touch sensitivity will be determined using a Cochet-Bonnet aesthesiometer mounted on a standard slit lamp biomicroscope. The Cochet-Bonnet aesthesiometer is routinely used for clinical research purposes to investigate corneal touch thresholds.
- For sensitivity measurements, a 0.12 mm diameter nylon thread will be slowly brought forward to briefly touch the cornea perpendicularly and then quickly withdrawn.
- On each occasion, the patient will be asked to respond whenever a stimulus is felt.
- Thread length is used to quantitatively assess sensitivity. The longest thread length is used first (6 cm), as this provides the lowest stimulus intensity.
- If the subject is unable to detect the touch stimulus, the thread will be systematically shortened in length by 0.5 cm steps until the stimulus is felt.
- The criterion for the sensitivity threshold will be the filament length which gives a 50% positive response from four stimulus applications.
In Vivo Confocal Microscope
- Corneal nerves will be imaged using a modified in vivo confocal microscope which is routinely used in our clinics (HRT Rostock corneal module, Heidelberg Engineering).
- The HRT In Vivo Confocal microscope was modified by adding a motor to automate the focus. This does not alter the integrity, the application, the intent or the light source of the instrument.
- Corneas will be anesthetized with a topical anesthetic, proparacaine, prior to scanning.
- The confocal microscope will briefly touch the patient's eye and the images saved for further analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sleep Apnea and normal controls
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corneal Sensitivity
Time frame: 1-Day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Robertson, O.D, PhD principal investigator
UTSW Medical Center at Dallas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Sensitivity (time frame: 1-Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.