UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059977 |
|---|---|
| Receipt number | R000068608 |
| Scientific Title | OSA in Glaucoma: Autonomic Dysfunction, Ocular Blood Flow, and CPAP Impact |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2025/12/04 17:51:51 |
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Basic information
Public title
A Prospective Study on Autonomic Function, Ocular Circulation, Optic Nerve Damage, and Long-Term CPAP Effects in Glaucoma Patients With Obstructive Sleep Apnea
Acronym
Autonomic Function and Ocular Circulation in Glaucoma With OSA
Scientific Title
OSA in Glaucoma: Autonomic Dysfunction, Ocular Blood Flow, and CPAP Impact
Scientific Title:Acronym
Pathophysiologic Mechanisms Linking OSA and Glaucoma
Region
| Japan |
Condition
Condition
glaucoma patients with sleep apnea syndrome
Classification by specialty
| Pneumology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1, Cross sectional study
To determine whether autonomic dysfunction characterized by reduced heart rate variability(HRV) and sympathetic predominance is associated with decreased optic nerve head blood flow (measured by LSFG), thinning of the nerve fiber, and visual field defect in glaucoma patients with sleep apnea syndrome (SAS).
2, Longitudinal study
Among glaucoma patients with SAS who initiate CPAP therapy, we will evaluate changes in autonomic indicators, ocular blood flow, and visual function from baseline to 15 months. We will also compare outcomes between patients with good versus poor CPAP adherence to clarify the long term effects of CPAP treatment.
Basic objectives2
Others
Basic objectives -Others
nothing particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1, Changes in HRV parameters
2, Changes in LSFG measurements.
3, Progression slopes of visual field MD and visual field sensitivity.
4, Comparison of the above changes between patients with good CPAP adherence (more than 4 h/night, more than 80%) and those with poor adherence.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 20 and 85 years.
2. Diagnosis of primary open-angle glaucoma (POAG) or normal-tension glaucoma (NTG) with well-controlled intraocular pressure.
3.Diagnosis of sleep apnea syndrome (SAS) based on PSG derived AHI.
4. For the CPAP longitudinal study: AHI more than 20 and judged to require CPAP therapy.
5. Ability to perform reliable visual field testing.
6. Provision of written informed consent.
Key exclusion criteria
1. Presence of arrhythmias or implanted pacemakers that interfere with HRV analysis.
2. Severe retinopathy, optic neuritis, or other optic nerve disorders not related to glaucoma.
3. Planned ophthalmic surgery during the observation period.
4. Presence of autoimmune diseases, hyperthyroidism, or other hormonal disorders.
5. Use of oral contraceptive pills.
6. Pregnant or planning to become pregnant or breastfeed during the study period.
7. Shift workers or individuals with irregular circadian rhythms.
8. Cases deemed inappropriate for participation by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | NORIKO |
| Middle name | |
| Last name | HIMORI |
Organization
TOHOKU UNIVERSITY
Division name
Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
0227177294
noriko.himori.b3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | NORIKO |
| Middle name | |
| Last name | HIMORI |
Organization
TOHOKU UNIVERSITY
Division name
Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
0227177294
Homepage URL
noriko.himori.b3@tohoku.ac.jp
Sponsor or person
Institute
TOHOKU UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TOHOKU UNIVERSITY
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
Tel
0227177294
noriko.himori.b3@tohoku.ac.jp
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
| 2026 | Year | 01 | Month | 19 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross sectional study, longitudinal study
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068608
