Sleep Apnea, Obstructive Clinical Trial
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
Verified date | December 2015 |
Source | Sensimed AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | The New York Eye and Ear Infirmary | New-York | New York |
Lead Sponsor | Collaborator |
---|---|
Sensimed AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
24 hours | No |
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 |
24-hours | No |
Secondary | Effect After CPAP Removal on the IOP Pattern | IOP pattern immediately after CPAP removal upon waking in patients with or without POAG | 30 min | No |
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