UMIN-CTR Clinical Trial

Public title

Study on Sleep Apnea Syndrome and Dysphagia

Acronym

Study on Sleep Apnea Syndrome and Dysphagia

Scientific Title

Study on Sleep Apnea Syndrome and Dysphagia

Scientific Title:Acronym

Study on Sleep Apnea Syndrome and Dysphagia

Region

Japan

Condition

sleep apnea syndrome

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess swallowing function in patients with obstructive sleep apnea (OSA).

Basic objectives2

Others

Basic objectives -Others

Evaluate tongue pressure and lip closure pressure in patients with obstructive sleep apnea (OSA).

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

strength of the swallowing muscles

Key secondary outcomes

tongue pressure,lip closure pressure,skeletal structure,patient's speech,soft palate and tongue properties

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

<OSA group>
1.Patients with polysomnography (PSG) diagnosis of OSA with AHI 5 or higher
2.Adult patients who are at least 18 years old at the time of consent
3.Patients whose medical information can be obtained from their medical records
4.Written consent for this study has been obtained from patients themselves.

<Aspiration pneumonia group>
1.Subjects who have been diagnosed with aspiration pneumonia.
2.Adult subjects who are at least 18 years old at the time of consent.
3. Subjects whose medical information can be obtained from their medical records
4. Written consent for this study has been obtained from subjects themselves.

<Non-sleep apnea (non-SA) and non-aspiration pneumonia group>
1.Subjects with an AHI of less than 5 on a simple SAS test or polysomnography (PSG).
2.Subjects who are attending a respiratory physician.
3.Subjects who have not been diagnosed with sleep apnea (SA).
4.Subjects who have not been diagnosed with aspiration pneumonia.
5.Adult subjects who are at least 18 years old at the time of consent.
6.Subjects whose medical information can be obtained from their medical records.
7.Written consent for this study has been obtained from subjects themselves.

Key exclusion criteria

<OSA group>
1.Patients diagnosed with central sleep apnea(CSA)
2.Patients who are judged to be inappropriate for this study by the principal investigator.

<Aspiration pneumonia group>
1.The principal investigator determines that the subject is inappropriate for this study.

<Non-SA non-aspiration pneumonia group>
1.The principal investigator determines that the subject is inappropriate for this study.

Target sample size

70

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Nagano

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Division name

Division of Respiratory Medicine

Zip code

650-0017

Address

5-2, 7-chome, Kusunoki-cho, Chuo-ku, Kobe City

TEL

0783825660

Email

tnagano@med.kobe-u.ac.jp

Name of contact person

1st name	Kiyoko
Middle name
Last name	Fukuda

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Division name

Division of Respiratory Medicine

Zip code

650-0017

Address

5-2, 7-chome, Kusunoki-cho, Chuo-ku, Kobe City

TEL

0783825660

Homepage URL

Email

kiyoko29@med.kobe-u.ac.jp

Institute

Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kobe University Hospital

Address

5-2,7-chome,Kusunoki-cho,Chuo-ku,Kobe City

Tel

0783826669

Email

chiken@med.kobe-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

10

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022

Year

10

Month

05

Day

Date of IRB

2023

Year

03

Month

17

Day

Anticipated trial start date

2023

Year

03

Month

17

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a cross-sectional study.

Registered date

2022

Year

10

Month

05

Day

Last modified on

2023

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055882