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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044187
Receipt No. 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

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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
Email 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
Email akanekohno@yahoo.co.jp

Sponsor
Institute Nippon Dental University Niigata
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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