UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039191 |
|---|---|
| Receipt number | R000044678 |
| Scientific Title | Potential Patient Screening for Late-Onset Pompe Disease in Suspected Sleep Apnea |
| Date of disclosure of the study information | 2020/01/17 |
| Last modified on | 2023/07/21 10:55:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Potential Patient Screening for Late-Onset Pompe Disease in Suspected Sleep Apnea
Acronym
Pompe in Suspected Sleep Apnea Population in Japan (PSSAP-J study)
Scientific Title
Potential Patient Screening for Late-Onset Pompe Disease in Suspected Sleep Apnea
Scientific Title:Acronym
Pompe in Suspected Sleep Apnea Population in Japan (PSSAP-J study)
Region
| Japan |
Condition
Condition
Late-Onset Pompe Disease
Classification by specialty
| Medicine in general | Pneumology | Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study are to clarify the prevalence of Late-onset Pompe disease (LOPD) in sleep lab-based population (primary outcome) and additionally to seek and identify information for early stage of LOPD which might be not only something in Sleep Disordered breathing (SDB)-like symptoms but also breathing behavior and SDB in the diagnostic polysomnography (PSG), those are secondary outcomes.
Basic objectives2
Others
Basic objectives -Others
Prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of LOPD among the enrolled participants.
Key secondary outcomes
The differences between LOPD patients and subject controls (non-LOPD) are compared regarding the presence of symptoms as well as findings in the diagnostic PSG.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who visit sleep lab by themselves and who are referred from general practitioners and/or other specialists including neurologist for the purpose of the evaluation of any sleep problem will be included. A range of age is limited from 18 to 80 years old.
Key exclusion criteria
Patients who are already diagnosed with a neurologic/neuromuscular disorder and who are previously diagnosed with sleep disordered breathing will be excluded. Also, patients who are under treatment for psychiatric disorders will be excluded as well.
In addition, patients whose body mass index (BMI) is more than 30 will be excluded.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Motoo |
| Middle name | |
| Last name | Yamauchi |
Organization
Nara Medical University
Division name
Department of Pathophysiology of Nursing
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
motoo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoo |
| Middle name | |
| Last name | Yamauchi |
Organization
Nara Medical University
Division name
Department of Pathophysiology of Nursing
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
Homepage URL
motoo@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Sanofi Genzyme
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
Tel
0744-22-3051
ino_rinri@naramed-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
奈良県立医科大学（奈良県）、千葉大学医学部（千葉県）、順天堂大学医学部（東京都）、新潟大学医学部（新潟県）、東京医科大学（東京都）、岩手医科大学（岩手県）、産業医科大学（福岡県）、関西電力病院（大阪府）、公立陶生病院（愛知県）、RESM新横浜 睡眠呼吸メディカルケアクリニック（神奈川県）、プラーナクリニック（埼玉県）、国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 17 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 06 | Month | 22 | Day |
Date analysis concluded
Other
Other related information
Study designed: A prospective multicenter observational cohort study in Japan
Subject population: Consecutive patients who visit sleep lab due to suspected SDB and who undergo overnight PSG
Management information
Registered date
| 2020 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044678
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
