UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the influence of hardness of air mattress on optional coughing power in sitting posture
Title of the study (Brief title)	Hardness of air mattress and breathing function
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	While air mattresses disperse body pressure and reduce local pressure, it has been reported that in the supine position the spinal curvature is enhanced, lowering coughing power and respiratory function. Even on a sitting posture (60 degrees of gathering up + 20 degrees of knee raising), spinal curvature arises on air mattresses and it is expected to reduce the optional coughing power. However, as far as the researchers were concerned, no report was found, so we reached the implementation of this research
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	peak cough flow
Key secondary outcomes	Age, gender, height, weight, BMI, grip strength, lung capacity, effortive lung capacity, 1 second rate, maximum inspiratory pressure, maximum expiratory pressure

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Take a gatch up sitting posture on the air mattress (pressure is set optimally)
Interventions/Control_2	Take a gatch up sitting posture on the air mattress (pressure is set optimally)
Interventions/Control_3	Take a gatch up sitting posture on the air mattress (pressure set to minimum)
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy adult with no history of respiratory disease or spinal column disease It is possible to acquire the consent of research participation by voluntary intention from the principal in writing Persons who do not suffer physical, mental and social disadvantages due to participation in this research Person who understands the clinical significance of this research and its importance
Key exclusion criteria	Women who are pregnant or have a possibility of pregnancy Those with pharyngeal pain Persons with common cold symptoms
Target sample size	20

Research contact person
Name of lead principal investigator	Tomohiro Ikeda
Organization	Okayama University Hospital
Division name	General rehabilitation department
Address	700-8558,Okayamashi,kitaku,ksikatacho,2-5-1
TEL	086-235-7752
Email	lirfranjitte@gmail.com

Public contact
Name of contact person	Tomohiro Ikeda
Organization	Okayama University Hospital
Division name	General rehabilitation department
Address	700-8558,Okyamashi,kitaku,sikatacho,2-5-1
TEL	086-235-7752
Homepage URL
Email	lirfranjitte@gmail.com

Sponsor
Institute	Okayama University Hospital General rehabilitation department
Institute
Department

Funding Source
Organization	Okayama University Hospital General rehabilitation department
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 08 Month 16 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2018 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031538