IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Ocular, Pulmonary |
| Therapuetic Areas: | Ophthalmology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | November 2012 |
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
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.
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.
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
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