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

NCT06152692 | Completed

• 1 other identifier: PI15/02179
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Circadian rhythms; Intraocular pressure

Outcome Measures

Primary Outcomes (3)

• Circadian rhythms

  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.

  At baseline and 12 months

• Circadian intraocular pressure patterns

  Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP.

  At baseline, 1 month and 12 months

• IOP-followed patterns

  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.

  At baseline and 12 months

Secondary Outcomes (2)

• Circadian rhythms

  At baseline and 12 months

• OSA and lax eyelid syndrome (SPL)

  At baseline and 12 months

Study Arms (3)

OSA + CPAP

EXPERIMENTAL

OSA + CPAP

Device: Continuous positive airway pressure

OSA + sham CPAP

PLACEBO COMPARATOR

OSA + sham CPAP

Device: SHAM Continuous positive airway pressure

Control

NO INTERVENTION

Control

Interventions

SHAM Continuous positive airway pressure DEVICE

Placebo treatment

Also known as: SHAM CPAP

OSA + sham CPAP

Continuous positive airway pressure DEVICE

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

Also known as: CPAP

OSA + CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Respiratory Medicine

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 31, 2018
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (1)