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

Sponsor

Sociedad Española de Neumología y Cirugía Torácica (Other)

Overall Status

Completed

CT.gov ID

NCT06152692

Collaborator

(none)

111

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: SHAM Continuous positive airway pressure Device: Continuous positive airway pressure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OSA + CPAP OSA + CPAP	Device: Continuous positive airway pressure Continuous positive airway pressure treatment for patients randomized to CPAP treatment group Other Names: CPAP
Placebo Comparator: OSA + sham CPAP OSA + sham CPAP	Device: SHAM Continuous positive airway pressure Placebo treatment Other Names: SHAM CPAP
No Intervention: Control Control

Arm

Intervention/Treatment

Experimental: OSA + CPAP

OSA + CPAP

Device: Continuous positive airway pressure

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

Other Names:

CPAP

Placebo Comparator: OSA + sham CPAP

OSA + sham CPAP

Device: SHAM Continuous positive airway pressure

Placebo treatment

Other Names:

SHAM CPAP

No Intervention: Control

Control

Outcome Measures

Primary Outcome Measures

Circadian rhythms [At 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.
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.
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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.