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

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01560975
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Primary Open-angle Glaucoma	Device: SENSIMED Triggerfish®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sensimed Triggerfish	Device: SENSIMED Triggerfish®; Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Outcome Measures

Primary Outcome Measures

1. Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG [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 Outcome Measures

1. Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters [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 [30 min]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT01560975
• Other Study ID Numbers: TF-1108
• First Posted: Mar 22, 2012
• Last Update Posted: Jan 27, 2016
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Glaucoma; Glaucoma, Open-Angle

Study Results

Participant Flow

Arm/Group Title	Sensimed Triggerfish
Arm/Group Description	SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sensimed Triggerfish
Arm/Group Description	SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (8.3)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG
Description	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
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POAG/CPAP	noPOAG/CPAP
Arm/Group Description	POAG patients with CPAP therapy	Subjects with CPAP
Measure Participants	4	4
Mean (Standard Deviation) [mVEq/h]	44.4 (34.8)	42.2 (40.7)

2. Secondary Outcome

Title	Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters
Description	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
Time Frame	24-hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POAG/CPAP	noPOAG/CPAP	POAG/no CPAP	noPOAG/ no CPAP
Arm/Group Description	POAG patients with CPAP therapy	no POAG patients with CPAP therapy	POAG patients without CPAP therapy	No POAG patients without CPAP therapy
Measure Participants	4	4	4	4
Mean (Standard Deviation) [Correlation]	0.36 (0.4)	0.92 (0.03)	0.47 (0.33)	0.42 (0.20)

3. Secondary Outcome

Title	Effect After CPAP Removal on the IOP Pattern
Description	IOP pattern immediately after CPAP removal upon waking in patients with or without POAG
Time Frame	30 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POAG/CPAP	noPOAG/CPAP	POAG/no CPAP	noPOAG/ no CPAP
Arm/Group Description	POAG patients with CPAP therapy	no POAG patients with CPAP therapy	POAG patients without CPAP therapy	No POAG patients without CPAP therapy
Measure Participants	4	4	4	4
Mean (Standard Deviation) [mvEq]	-2.6 (54)	-25.4 (69.1)	-40.4 (89.2)	-50.3 (91.2)

Adverse Events

Arm/Group Title	Sensimed Triggerfish
Arm/Group Description	SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
All Cause Mortality
	Sensimed Triggerfish
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sensimed Triggerfish
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Sensimed Triggerfish
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.