IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sensimed Triggerfish	SENSIMED Triggerfish®	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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