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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01560975
First received: March 20, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Primary Open-angle Glaucoma
Device: SENSIMED Triggerfish®

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Explorative, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Moderate to Severe Obstructive Sleep Apnea Syndrome Using Continuous Positive Airway Pressure With or Without Primary Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Relationship between IOP fluctuation pattern with or without CPAP therapy in patients with moderate to severe OSAS with or without POAG [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Relationship between the 24-hour IOP fluctuation patterns and physiologic parameters, with or without CPAP therapy in patients with moderate to severe OSAS, with or without POAG [ Time Frame: 24-hours ] [ Designated as safety issue: No ]

    Heart rate and ocular pulsation rate during sleep:

    • using CPAP in patients with or without POAG
    • not using CPAP in patients with or without POAG

  • Effect after CPAP removal on the IOP pattern [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    IOP pattern immediately after CPAP removal upon waking in patients with or without POAG


Enrollment: 10
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensimed Triggerfish Device: SENSIMED Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560975

Locations
United States, New York
The New York Eye and Ear Infirmary
New-York, New York, United States, 10003
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Robert Ritch, MD The New York Eye and Ear infirmary
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01560975     History of Changes
Other Study ID Numbers: TF-1108
Study First Received: March 20, 2012
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Glaucoma
Glaucoma, Open-Angle
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Ocular Hypertension
Eye Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014