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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Continuous positive airway pressure; Device: SHAM Continuous positive airway pressure

• Registration Number: NCT06152692
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-06
• Study Completion: 2018-12-31
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA + CPAP	Continuous positive airway pressure	OSA + CPAP
OSA + sham CPAP	SHAM Continuous positive airway pressure	OSA + sham CPAP

Primary Outcome Measures

Name	Time	Method
Circadian intraocular pressure patterns	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.
Circadian rhythms	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.
IOP-followed patterns	At baseline and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
OSA and lax eyelid syndrome (SPL)	At baseline and 12 months	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.
Circadian rhythms	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.

Trial Locations

Locations (1)

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain