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

Sociedad Española de Neumología y Cirugía Torácica

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Continuous positive airway pressure; Device: SHAM Continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06152692

PI15/02179

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups, including a placebo group

OSA + CPAP

Experimental group

Description:

OSA + CPAP

Treatment:

Device: Continuous positive airway pressure

OSA + sham CPAP

Placebo Comparator group

Description:

OSA + sham CPAP

Treatment:

Device: SHAM Continuous positive airway pressure

Control

No Intervention group

Description:

Control