UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057344 |
|---|---|
| Receipt number | R000065542 |
| Scientific Title | An Exploratory Clinical Study for Screening Indicators for Sleep-Related Breathing Disorders (SRBD) in Perimenopausal and Postmenopausal Women with Menopausal Symptoms |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/19 16:47:49 |
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Basic information
Public title
An Exploratory Clinical Study for Screening Indicators for Sleep-Related Breathing Disorders (SRBD) in Perimenopausal and Postmenopausal Women with Menopausal Symptoms
Acronym
An Exploratory Clinical Study for Screening Indicators for Sleep-Related Breathing Disorders (SRBD) in Perimenopausal and Postmenopausal Women with Menopausal Symptoms
Scientific Title
An Exploratory Clinical Study for Screening Indicators for Sleep-Related Breathing Disorders (SRBD) in Perimenopausal and Postmenopausal Women with Menopausal Symptoms
Scientific Title:Acronym
An Exploratory Clinical Study for Screening Indicators for Sleep-Related Breathing Disorders (SRBD) in Perimenopausal and Postmenopausal Women with Menopausal Symptoms
Region
| Japan |
Condition
Condition
Perimenopausal and postmenopausal menopausal syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the current status of potential SAS in women with menopausal symptoms.
Basic objectives2
Others
Basic objectives -Others
To improve the quality of life and extend the healthy life span of women by diagnosing sleep-related breathing disorders underlying insomnia, one of the symptoms of menopause.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the prevalence and severity of potential sleep-related breathing disorders (SRBD) in perimenopausal and postmenopausal patients with menopausal symptoms.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear a portable sleep apnea test (SAS-2200) for one night only
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Patients undergoing perimenopause or postmenopausal menopause as outpatients
(2) Those who have given written consent to participate in this study.
Key exclusion criteria
(1) Those who have requested not to participate in this study based on the information disclosed
(2) Patients whose safety is deemed to be difficult to ensure based on the judgment of the physician
(3) Patients diagnosed with an active malignant disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | KINOSHITA |
Organization
Kurume University School of medicine
Division name
Division of Respirology, Neurology & Rheumatokogy. Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume city
TEL
0942-35-3311
tkino@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKASHI |
| Middle name | |
| Last name | KINOSHITA |
Organization
Kurume University School of medicine
Division name
Division of Respirology, Neurology & Rheumatokogy. Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume city
TEL
0942-35-3311
Homepage URL
tkino@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kurume University Hospital
Address
67 Asahi-machi, Kurume city, Fukuoka
Tel
0942-65-3749
i_rinri@kurume-u.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
| 2025 | Year | 03 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065542
