UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060444 |
|---|---|
| Receipt number | R000069129 |
| Scientific Title | Impact of Sleep Apnea Therapy on Swallowing Function: A Cross-Sectional Compatison |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/01/22 17:05:39 |
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Basic information
Public title
A study investigating whether sleep apnea treatment affects swallowing function
Acronym
Sleep Apnea Therapy and Swallowing Function
Scientific Title
Impact of Sleep Apnea Therapy on Swallowing Function: A Cross-Sectional Compatison
Scientific Title:Acronym
Impact of Sleep Apnea Therapy on Swallowing Function
Region
| Japan |
Condition
Condition
Obstructive sleep apnea (OSA)
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Oral surgery |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether OSA treatment influences swallowing-related symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total and individual item scores of the Seirei Dysphagia Screening Questionnaire
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Untreated patients, including those prior to initiating OSA therapy
Patients who met the Japanese health insurance criteria for CPAP coverage and were receiving either CPAP therapy or CPAP with OA therapy.
Key exclusion criteria
Poor CPAP adherence
Prior diagnosis of dysphagia
Severe asthma or Chronic obstructive pulmonary disease (COPD)
Neurodegenerative diseases or neuromuscular disorders
History of stroke
History of head and neck surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kohno |
Organization
Yamato Hidakamikai Medical Corporation,
Division name
Kobayashi Internal Medicine Clinic
Zip code
950-0914
Address
6-2-26, Shichikuyama, Chuo-ku, Niigata City, Niigata, 950-0914, JAPAN
TEL
025-246-5600
ma-kohno@sleptwel.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Kohno |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Dysphagia Rehabilitati
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata City, Niigata, 951-8514, JAPAN
TEL
025-227-2999
Homepage URL
akanekohno@yahoo.co.jp
Sponsor or person
Institute
Yamato Hidakami Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Yamato Hidakami Medical Corporation
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
Institutional Review Board of the Yamato Hidakami Medical Corporation
Address
6-2-26, Shichikuyama, Chuo-ku, Niigata City, Niigata, 950-0914, JAPAN
Tel
025-246-5600
ma-kohno@sleptwel.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 | 07 | Month | 31 | 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
400
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection completed.
Management information
Registered date
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069129
