Sleep at 30 Degrees in Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleeping position in glaucoma patient
Sponsored by
About this trial
This is an interventional trial for Glaucoma focused on measuring progressive glaucoma despite controlled IOP
Eligibility Criteria
Inclusion Criteria:
- This pilot study included patients with progressive NTG or POAG as evidenced by disc hemorrhage despite well controlled Intraocular pressures (IOP), who were able to sleep flat
Exclusion Criteria:
- Any patients who were not able to sign a consent or lying flat during sleep
Sites / Locations
- Toronto Western Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00802061
First Posted
December 2, 2008
Last Updated
December 3, 2008
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00802061
Brief Title
Sleep at 30 Degrees in Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to investigate the effect of body posture (particularly when sleeping) on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma where a significant change i.e. a disc hemorrhage has occurred) is not known.
The study will involve being admitted to the Sleep Unit of the University Health Network at Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2 hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until the patients reach their normal sleep cycle time. Patients will then be asked to sleep in either lying down or reclining at a 30 degrees position and have the IOP measurements and brachial BP every 2 hours in that position.
The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement but will change their position, i.e. sitting before will now be supine and vice versa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
progressive glaucoma despite controlled IOP
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Sleeping position in glaucoma patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
This pilot study included patients with progressive NTG or POAG as evidenced by disc hemorrhage despite well controlled Intraocular pressures (IOP), who were able to sleep flat
Exclusion Criteria:
Any patients who were not able to sign a consent or lying flat during sleep
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Sleep at 30 Degrees in Glaucoma
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