UMIN-CTR Clinical Trial

Basic information
Public title	Prospective analyses of effects of head positions on apnea-hypopnea index in obstructive sleep apnea patients
Acronym	Effects of head positions on AHI in OSA patients
Scientific Title	Prospective analyses of effects of head positions on apnea-hypopnea index in obstructive sleep apnea patients
Scientific Title:Acronym	Effects of head positions on AHI in OSA patients
Region	Japan

Condition
Condition	Obstructive Sleep Apnea Syndrome
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This prospective single institutional study is designed to analyze effects of head positions on apnea-hypopnea index (AHI) by measuring head and body positions simultaneously with full polysomnography (PSG).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Analyze effects of head positions on AHI
Key secondary outcomes	1)Effects of body weight, neck circumference and abdominal circumference on phase differences between head and body positions 2)Effects of body positions on AHI 3)Relationships between sleep stages and AHI alteration induced by head and body positions

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients suspected with OSA who were admitted to the Sleep Center of Tokai University Hospital (Isehara, Japan)
Key exclusion criteria	Patients less than 20 years old are excluded. Patients who are considered as inappropriate for this study by the investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuya Aoki
Organization	The Sleep Center of Tokai University Hospital
Division name	Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Zip code
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Email	aokitaku@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takuya Aoki
Organization	The Sleep Center of Tokai University Hospital
Division name	Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Zip code
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Homepage URL
Email	aokitaku@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University Hospital
Institute
Department

Funding Source
Organization	The Sleep Center of Tokai University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2019 Year 01 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 11 Month 15 Day
Date of IRB	2018 Year 11 Month 30 Day
Anticipated trial start date	2019 Year 01 Month 24 Day
Last follow-up date	2020 Year 11 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Termination of this observational study

Management information
Registered date	2019 Year 01 Month 17 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040536