UMIN-CTR Clinical Trial

Public title

Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome

Acronym

Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome (MFIT Study)

Scientific Title

Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome

Scientific Title:Acronym

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

Sleep Apnea Syndrome

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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)

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masazumi Komagamine

Organization

Komagamine Clinic

Division name

The Center for Sleep Disordered Breathing

Zip code

Address

4-6, Nishi-Sinjuku 4-chome, Sinjuku-ku, Tokyo, Japan

TEL

03-5333-8595

Email

moriyama@ibiki-mukokyu.jp

Name of contact person

1st name
Middle name
Last name	Kiyoshi Moriyama

Organization

Komagamine Clinic

Division name

The Center for Sleep Disordered Breathing

Zip code

Address

4-6, Nishi-Sinjuku 4-chome, Sinjuku-ku, Tokyo, Japan

TEL

03-5333-8595

Homepage URL

Email

moriyama@ibiki-mukokyu.jp

Institute

The Center for Sleep Disordered Breathing, Komagamine Clinic

Institute

Department

Personal name

Organization

Teijin Pharma Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2016

Year

06

Month

07

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2016

Year

05

Month

20

Day

Date of IRB

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

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.

Registered date

2016

Year

06

Month

07

Day

Last modified on

2018

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026100