UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044187 |
|---|---|
| Receipt number | R000050460 |
| Scientific Title | Retrospective observational study of swallowing during sleep in obstructive sleep apnea patients using polysomnography |
| Date of disclosure of the study information | 2021/05/12 |
| Last modified on | 2021/10/21 10:12:57 |
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Basic information
Public title
Observational study of swallowing during sleep in obstructive sleep apnea patients
Acronym
Observational study of swallowing during sleep
Scientific Title
Retrospective observational study of swallowing during sleep in obstructive sleep apnea patients using polysomnography
Scientific Title:Acronym
Retrospective observational study of swallowing during sleep using polysomnography
Region
| Japan |
Condition
Condition
Aspiration during sleep
Classification by specialty
| Medicine in general | Oto-rhino-laryngology | Oral surgery |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Are the frequency of swallowing during sleep observed by polysomnography affected by the severity of obstructive sleep apnea syndrome?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the frequency of swallowing muscle activity with and without swallowing apnea, and AHI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the Dental Sleep Medicine Center at Nippon Dental University Niigata Hospital and underwent polysomnography for detailed examination of obstructive sleep apnea
Key exclusion criteria
deglutition disorder
neurological disorders
respiratory disorders
maxillofacial morphology requiring surgical treatment
odontoparallaxis
malocclusion
abnormalities in EEG or ECG
sleep disorders other than breathing difficulties
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Ohkoshi |
Organization
Nippon Dental University Niigata
Division name
Internal medicine
Zip code
951-8580
Address
Hamauracho 1-8, Chuo-Ku, Niigata City, 951-8580, JPN
TEL
025-211-8243
okoshi@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Kohno |
Organization
Nippon Dental University Niigata
Division name
Internal medicine
Zip code
951-8580
Address
Hamauracho 1-8, Chuo-Ku, Niigata City 951-8580, JPN
TEL
025-267-1500(3741)
Homepage URL
akanekohno@yahoo.co.jp
Sponsor or person
Institute
Nippon Dental University Niigata
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Ethical review committee of Nippon Dental University at Niigata
Address
Hamauracho 1-8, Chuo-Ku, Niigata City 951-8580, JPN
Tel
025-267-1500
www@ngt.ndu.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
| 2021 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 07 | Day |
Other
Other related information
sample:
Polysomnography and cephalogram data of patients who visited the Dental Sleep Medicine Center at Nippon Dental University Niigata Hospital and underwent polysomnography for detailed examination of obstructive sleep apnea (20 consecutive patients from the healthy control group and from each OSA severity group (mild, moderate, and severe), dating back from January 15, 2021 for each severity).
Method:
The frequency of swallowing events is compared among the different OSA severity groups.
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050460
