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Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common sleep-related breathing disorder and is characterized by repeated partial or complete upper airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The association between OSAS and glaucoma has been extensively studied, although a few reports have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.
The purpose of this study is to investigate how IOP varies in time, particularly during sleep in OSAS patients with or without glaucoma, and if the IOP variations are associated with the use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensimed Triggerfish | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish® | Device | Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG | 24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | Heart rate and ocular pulsation rate during sleep:
| 24-hours |
| Effect After CPAP Removal on the IOP Pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Ritch, MD | The New York Eye and Ear infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensimed Triggerfish | SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensimed Triggerfish | SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG | 24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.
| Posted | Mean | Standard Deviation | mVEq/h | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sensimed Triggerfish | SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Ritch | NYEE | +1 212 477 7540 | ritchmd@earthlink.net |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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IOP pattern immediately after CPAP removal upon waking in patients with or without POAG |
| 30 min |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | Heart rate and ocular pulsation rate during sleep:
| Posted | Mean | Standard Deviation | Correlation | 24-hours |
|
|
|
| Secondary | Effect After CPAP Removal on the IOP Pattern | IOP pattern immediately after CPAP removal upon waking in patients with or without POAG | Posted | Mean | Standard Deviation | mvEq | 30 min |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |