UMIN-CTR Clinical Trial

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