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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA + CPAP | Experimental | OSA + CPAP |
|
| OSA + sham CPAP | Placebo Comparator | OSA + sham CPAP |
|
| Control | No Intervention | Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHAM Continuous positive airway pressure | Device | Placebo treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circadian rhythms | 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. | At baseline and 12 months |
| Circadian intraocular pressure patterns | Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP. | At baseline, 1 month and 12 months |
| IOP-followed patterns | 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. | At baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian rhythms | 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. | At baseline and 12 months |
| OSA and lax eyelid syndrome (SPL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
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| Continuous positive airway pressure | Device | Continuous positive airway pressure treatment for patients randomized to CPAP treatment group |
|
|
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. |
| At baseline and 12 months |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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