Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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OSA + CPAP

Group Type EXPERIMENTAL

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure treatment for patients randomized to CPAP treatment group

OSA + sham CPAP

Group Type PLACEBO_COMPARATOR

SHAM Continuous positive airway pressure

Intervention Type DEVICE

Placebo treatment

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SHAM Continuous positive airway pressure

Placebo treatment

Intervention Type DEVICE

Continuous positive airway pressure

Continuous positive airway pressure treatment for patients randomized to CPAP treatment group

Intervention Type DEVICE

Other Intervention Names

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SHAM CPAP CPAP

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No