Sleep at 30 Degrees in Glaucoma

This study has been completed.

Sponsor:

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00802061

First received: December 2, 2008

Last updated: December 3, 2008

Last verified: December 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	December 2, 2008
Last Updated Date	December 3, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00802061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Sleep at 30 Degrees in Glaucoma
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Behavioral: Sleeping position in glaucoma patient
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00802061
Other Study ID Numbers ^ICMJE	Trope 003
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	University Health Network, Toronto
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Health Network, Toronto
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top