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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017950
Receipt No. 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

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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
Email 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
Email riki-k@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020759

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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