Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
The purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and glaucoma.
OBJECTIVES: 1. To study the PIO and its fluctuations in patients with SAHS before starting treatment with CPAP. Objective 2. To assess the effect of CPAP on circadian IOP patterns. 3. Evaluate the effect of changes in IOP in patients with OSA treated with CPAP in the nerve fiber layer of the retina.
METHODS: A prospective study to be monitored continuously for 24 hours IOP by contact lens device Sensimed Triggerfish (Sensimed AG, Switzerland). Objective 1. To monitore and compare the IOP for 24 hours at 74 patients diagnosed with SAHS before starting treatment with CPAP and 37 patients without OSA. Objective 2. To study the impact of CPAP treatment by a study design in two stages CPAP / sham CPAP. A first monitoring of IOP will be compared before starting treatment with CPAP, with monitoring a month (CPAP-sham CPAP) and 12 months after initiation of treatment with CPAP. Objective 3. To correlate the values obtained from the monitoring of IOP in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with CPAP.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lleida, Spain, 25198
- Hospital Universitari Arnau de Vilanova
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years of age
- Seeking a sleep study using a cardio-respiratory polygraph study
- Having spherical refraction between -5D and 3D, cylinder correction <2D, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle
Exclusion Criteria:
- Presence of severe drowsiness or risk profession that requires urgent treatment with CPAP
- Any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery.
- Glaucoma patients will be excluded at the start of the study.
- When both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
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Experimental: OSA + CPAP
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Continuous positive airway pressure treatment for patients randomized to CPAP treatment group
Other Names:
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Placebo Comparator: OSA + sham CPAP
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Placebo treatment
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circadian intraocular pressure patterns
Time Frame: At baseline, 1 month and 12 months
|
Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP.
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At baseline, 1 month and 12 months
|
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IOP-followed patterns
Time Frame: At baseline and 12 months
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Correlate IOP-followed patterns for 24 hours in OSA patients with changes in retinal nerve fiber layer thickness from the start of the study and after 12 months of follow-up.
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At baseline and 12 months
|
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Circadian rhythms
Time Frame: At baseline and 12 months
|
Compare the circadian rhythms of continuously measured intraocular pressure for 24 hours between patients diagnosed with OSA before initiating CPAP treatment and a group of subjects without OSA.
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At baseline and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circadian rhythms
Time Frame: At baseline and 12 months
|
Correlate circadian rhythms followed by IOP as well as changes in the retinal nerve fiber layer with cardio-respiratory polygraphic variables to detect possible risk factors for glaucoma among the OSA population.
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At baseline and 12 months
|
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OSA and lax eyelid syndrome (SPL)
Time Frame: At baseline and 12 months
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Analyze whether OSA patients who also have lax eyelid syndrome (SPL) have higher or more fluctuating intraocular pressure values that help explain the higher prevalence of glaucoma among patients with OSA and SPL.
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At baseline and 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI15/02179
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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