IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure

NCT01560975 | Completed Results

• 1 other identifier: TF-1108
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common sleep-related breathing disorder and is characterized by repeated partial or complete upper airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The association between OSAS and glaucoma has been extensively studied, although a few reports have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime. The purpose of this study is to investigate how IOP varies in time, particularly during sleep in OSAS patients with or without glaucoma, and if the IOP variations are associated with the use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.

Conditions

Sleep Apnea, Obstructive; Primary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG

  24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG

  24 hours

Secondary Outcomes (2)

• Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters

  24-hours

• Effect After CPAP Removal on the IOP Pattern

  30 min

Study Arms (1)

Sensimed Triggerfish

EXPERIMENTAL

Device: SENSIMED Triggerfish®

Interventions

SENSIMED Triggerfish® DEVICE

Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Sensimed Triggerfish

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of moderate to severe OSAS, determined by a RDI \> 15 on PSG
• Patient has either POAG with controlled IOP or no glaucoma. Five of each will included in the study
• Patients under CPAP therapy
• Aged ≥ 18 years, of either sex
• Not more than 4 diopters spherical equivalent on the study eye
• Not more than 2 diopters cylinder equivalent on the study eye
• Have given written informed consent, prior to any investigational procedures

You may not qualify if:

• Sleep disorders other than OSAS
• Use of sleep medication
• Patients with history of intraocular surgery (including laser therapy) within the last 3 months
• Corneal or conjunctival abnormality hindering contact lens adaptation
• Severe dry eye syndrome
• Patients with allergy to corneal anesthetic
• Patients with contraindications for silicone contact lens wear
• Patients not able to understand the character and individual consequences of the investigation
• Participation in other clinical research within the last 30 days

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

The New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr. Robert Ritch
• Organization: NYEE

ritchmd@earthlink.net

+1 212 477 7540

Study Officials

• Robert Ritch, MD

  The New York Eye and Ear infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 27, 2016
• Results First Posted: November 24, 2014

Record last verified: 2015-12

Locations

US (1)