UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome
Title of the study (Brief title)	Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome (MFIT Study)
Region	Japan

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

Objectives
Narrative objectives1	To examine association between suitability of mask for Continuous Positive Airway Pressure (CPAP) therapy and morphology of face in Japanese patients with sleep apnea syndrome (SAS).
Basic objectives2	Others
Basic objectives -Others	Association between suitability of CPAP mask and morphology of face.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Morphology of face. - Nose breadth - Nasal root breadth - Nasal root depth
Key secondary outcomes	Evaluation of pain by Verbal Rating Scale (VRS) Physical size (Height, Weight, Body Mass Index(BMI)) CPAP Treatment data (Leak, Hour of use, Apnea Hypopnea Index (AHI), Model of CPAP, Model and size of mask, CPAP pressure, History of CPAP therapy, History of mask usage)

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	(1) Patient with sleep apnea syndrome (SAS) (2) Patient who continued continuous positive airway pressure (CPAP) therapy for 1 year or more at informed consent (IC) acquisition. (3) Patient who used only one model and one size of mask for CPAP therapy for 1 year or more at IC acquisition. (4) Patients whose prescription on CPAP therapy [pressure, operation mode, expiratory pressure relief (EPR)] was not changed for 1 year or more at IC acquisition. (5) Patients who used Autoset C, Sleepmate S9 Elite or Sleepmate S9 Auto for CPAP therapy. (6) Patients whose operation mode of equipment for CPAP therapy was CPAP mode. (7) Patients whose age was 20 years or more at IC acquisition. (8) Patients who gave written IC.
Key exclusion criteria	(1) Patients incapable of measuring accurate leak by opening mouth during CPAP therapy. (2) Patient with or suspected of nasal obstruction. (3) Patients for whom it's difficult to answer right by dementia and/or psychological disorder. (4) Patient receiving public assistance. (5) Patient with a history of epileptic seizure. (6) Patients whom the attending physician has considered ineligible for this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Masazumi Komagamine
Organization	Komagamine Clinic
Division name	The Center for Sleep Disordered Breathing
Address	4-6, Nishi-Sinjuku 4-chome, Sinjuku-ku, Tokyo, Japan
TEL	03-5333-8595
Email	moriyama@ibiki-mukokyu.jp

Public contact
Name of contact person	Kiyoshi Moriyama
Organization	Komagamine Clinic
Division name	The Center for Sleep Disordered Breathing
Address	4-6, Nishi-Sinjuku 4-chome, Sinjuku-ku, Tokyo, Japan
TEL	03-5333-8595
Homepage URL
Email	moriyama@ibiki-mukokyu.jp

Sponsor
Institute	The Center for Sleep Disordered Breathing, Komagamine Clinic
Institute
Department

Funding Source
Organization	Teijin Pharma Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	駒ヶ嶺医院睡眠呼吸センター（東京都）／The Center for Sleep Disordered Breathing, Komagamine Clinic

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 17 Day
Last follow-up date	2016 Year 10 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 17 Day
Date trial data considered complete
Date analysis concluded	2018 Year 07 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	- Study design: Single-center, cross section, observational study. - Sampling of the subject candidate: Check the eligibility of each patient consecutively from outpatients of study institution based on medical record. - Period for informed consent: from June 1 to September 30 2016.

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026100