Clinical trial NCT06152692: Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
Official title: Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Circadian rhythms
Intraocular pressure
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Circadian rhythms
timeFrame: At baseline and 12 months
measure: Circadian intraocular pressure patterns
timeFrame: At baseline, 1 month and 12 months
measure: IOP-followed patterns
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Circadian rhythms
timeFrame: At baseline and 12 months
measure: OSA and lax eyelid syndrome (SPL)
timeFrame: At baseline and 12 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
References: