Clinical trial NCT01560975: IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
Official title: A Prospective, Explorative, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Moderate to Severe Obstructive Sleep Apnea Syndrome Using Continuous Positive Airway Pressure With or Without Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Primary Open-angle Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG
timeFrame: 24 hours
Secondary outcomes:
measure: Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters
timeFrame: 24-hours
measure: Effect After CPAP Removal on the IOP Pattern
timeFrame: 30 min
Other outcomes:
Locations:
city: New-York
country: United States
facility: The New York Eye and Ear Infirmary
state: New York
Study officials:
affiliation: The New York Eye and Ear infirmary
name: Robert Ritch, MD
role: PRINCIPAL_INVESTIGATOR
References: