UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055864 |
|---|---|
| Receipt number | R000063847 |
| Scientific Title | Pseudo interferential current stimulation for sleep apnea syndrome: A preliminary study |
| Date of disclosure of the study information | 2024/10/20 |
| Last modified on | 2025/10/25 14:43:12 |
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Basic information
Public title
Pseudo interferential current stimulation for sleep apnea syndrome: A preliminary study
Acronym
Pseudo interferential current stimulation for sleep apnea syndrome: A preliminary study
Scientific Title
Pseudo interferential current stimulation for sleep apnea syndrome: A preliminary study
Scientific Title:Acronym
Pseudo interferential current stimulation for sleep apnea syndrome: A preliminary study
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of pseudo interferential current stimulation for sleep apnea syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of apnea-hypopnea index before and after performing pseudo interferential current stimulation
Key secondary outcomes
1. Change of 3%ODI before and after performing pseudo interferential current stimulation
2. Change of minimum SpO2 before and after performing pseudo interferential current stimulation
3. Change of time of SpO2<90% before and after performing pseudo interferential current stimulation
4. Change of snoring before and after performing pseudo interferential current stimulation
5. Change of JESS scores before and after performing pseudo interferential current stimulation
6. Change of PSQI scores before and after performing pseudo interferential current stimulation
7. Adherence to pseudo interferential current stimulation
8. Effect of pseudo interferential current stimulation according to Mallampati scores
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Pseudo interferential current stimulation
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. Patients with sleep apnea syndrome who are followed up at Kyoto University Hospital
2. Patients with 5-30 events/h of apnea-hypopnea index evaluated via out of center sleep testing
Key exclusion criteria
1. Patients with implantable electronic devices such as cardiac pacemaker
2. Patients with arrhythmia, epilepsy, malignancies, cervical unstable atheromatous plaque
3. Patients with atopic dermatitis and skin ulcer
4. Patients during pregnancy
5. Patients using oral appliance and continuous positive airway pressure device
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hirai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0745-751-3830
sh1124@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3852
Homepage URL
ssato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Toyohiro Hirai
Funding Source
Organization
Nothing
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063847
