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

March 20, 2012
May 12, 2014
March 2012
November 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01560975 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Sleep Apnea, Obstructive
  • Primary Open-angle Glaucoma
Device: SENSIMED Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Experimental: Sensimed Triggerfish
Intervention: Device: SENSIMED Triggerfish®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01560975
TF-1108
No
Sensimed AG
Sensimed AG
Not Provided
Principal Investigator: Robert Ritch, MD The New York Eye and Ear infirmary
Sensimed AG
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP