Primary Open-angle Glaucoma, Sleep Apnea, Obstructive
Conditions
Brief summary
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.
Interventions
DEVICESENSIMED Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a confirmed diagnosis of moderate to severe OSAS, determined by a RDI \> 15 on PSG * Patient has either POAG with controlled IOP or no glaucoma. Five of each will included in the study * Patients under CPAP therapy * Aged ≥ 18 years, of either sex * Not more than 4 diopters spherical equivalent on the study eye * Not more than 2 diopters cylinder equivalent on the study eye * Have given written informed consent, prior to any investigational procedures
Exclusion criteria
* Sleep disorders other than OSAS * Use of sleep medication * Patients with history of intraocular surgery (including laser therapy) within the last 3 months * Corneal or conjunctival abnormality hindering contact lens adaptation * Severe dry eye syndrome * Patients with allergy to corneal anesthetic * Patients with contraindications for silicone contact lens wear * Patients not able to understand the character and individual consequences of the investigation * Participation in other clinical research within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG | 24 hours | 24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | 24-hours | Heart rate and ocular pulsation rate during sleep: * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG |
| Effect After CPAP Removal on the IOP Pattern | 30 min | IOP pattern immediately after CPAP removal upon waking in patients with or without POAG |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sensimed Triggerfish SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Sensimed Triggerfish |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POAG/CPAP | Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG | 44.4 mVEq/h | Standard Deviation 34.8 |
| noPOAG/CPAP | Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG | 42.2 mVEq/h | Standard Deviation 40.7 |
Secondary
Effect After CPAP Removal on the IOP Pattern
IOP pattern immediately after CPAP removal upon waking in patients with or without POAG
Time frame: 30 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POAG/CPAP | Effect After CPAP Removal on the IOP Pattern | -2.6 mvEq | Standard Deviation 54 |
| noPOAG/CPAP | Effect After CPAP Removal on the IOP Pattern | -25.4 mvEq | Standard Deviation 69.1 |
| POAG/no CPAP | Effect After CPAP Removal on the IOP Pattern | -40.4 mvEq | Standard Deviation 89.2 |
| noPOAG/ no CPAP | Effect After CPAP Removal on the IOP Pattern | -50.3 mvEq | Standard Deviation 91.2 |
Secondary
Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters
Heart rate and ocular pulsation rate during sleep: * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG
Time frame: 24-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POAG/CPAP | Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | 0.36 Correlation | Standard Deviation 0.4 |
| noPOAG/CPAP | Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | 0.92 Correlation | Standard Deviation 0.03 |
| POAG/no CPAP | Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | 0.47 Correlation | Standard Deviation 0.33 |
| noPOAG/ no CPAP | Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters | 0.42 Correlation | Standard Deviation 0.2 |