UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017950 |
|---|---|
| Receipt number | R000020759 |
| Scientific Title | Fluctuations of intraocular pressure during nocturnal sleep in the patients with obstructive sleep apnea |
| Date of disclosure of the study information | 2015/06/18 |
| Last modified on | 2015/09/09 14:39:09 |
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Basic information
Public title
Fluctuations of intraocular pressure during nocturnal sleep in the patients with obstructive sleep apnea
Acronym
Nocturnal intraocular pressure in obstructive sleep apnea
Scientific Title
Fluctuations of intraocular pressure during nocturnal sleep in the patients with obstructive sleep apnea
Scientific Title:Acronym
Nocturnal intraocular pressure in obstructive sleep apnea
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Pneumology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study to evaluate the intraocular pressure (IOP) fluctuations during sleep in the patients with obstructive sleep apnea syndrome (OSAS) using the SENSIMED Triggerfish contact lens sensor (CLS).
Basic objectives2
Others
Basic objectives -Others
To evaluate the intraocular pressure
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Continuous IOP measurement
Key secondary outcomes
Heart rate
Respiratory rate
Oxygen saturation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The enrollees were admitted overnight for continuous IOP monitoring using the SENSIMED Triggerfish CLS (Sensimed AG, Lausanne, Switzerland). They underwent Sandman Elite polysomnograpy (Version 7.2, Embla Systems LLC, Ottawa, Canada) concurrently.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient age of 20 years or older at the time of obtaining informed consent
2.Glaucoma patients with SAS was suspected in the interview, or SAS patients without galucoma
3.Patients after receiving a sufficient explanation upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the patient himself.
Key exclusion criteria
1.Patients to merge the disease that produces a field of view failure in addition to glaucoma
2.Patients wearing contact lenses is not possible in severe dry eye
3.Some of the history of complications or infection of the eye associated with contact lens wear
4.Patients with active infection in their eyes
5.Patients with ocular trauma
6.Patients who recently underwent eye surgery
7.Patients with a history of silicon allergy
8.Patients with hypersensitivity to the tape and seal
9.Patients with a history of dry eye
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shinmei |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
N-15, W-7, Kita-ku, 060-8638, Sapporo, Japan
TEL
011-706-5944
yshinmei@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Riki Kijima |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Hokkaido University Graduate School of Medicine; N-15, W-7, Kita-ku, 060-8638, Sapporo, Japan
TEL
011-706-5944
Homepage URL
riki-k@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Allthe patients showed lower mean IOP levels during apnea events than during non-apnea phases, with statistically significant differences detected in 4 of the 7 patients. On an average of all 7 eyes.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On an average of the 7 eyes examined, IOP values significantly (p = 9.2E-6) decreased by 23.1 mV eq in relation to events.
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2015 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020759
