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OpenTrials
Completed

NCT Number: NCT01560975

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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Eye Diseases Glaucoma Glaucoma, Open-Angle Nervous System Diseases Ocular Hypertension Primary Open-Angle Glaucoma Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The New York Eye and Ear Infirmary

New York, 10003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish®

Device

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

Primary outcomes

  1. 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

    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 outcomes

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

    Time frame: 24-hours

    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

  2. Effect After CPAP Removal on the IOP Pattern

    Time frame: 30 min

    IOP pattern immediately after CPAP removal upon waking in patients with or without POAG

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2012
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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