UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041797
Receipt number R000047624
Scientific Title Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan
Date of disclosure of the study information 2020/09/15
Last modified on 2022/09/20 09:13:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan

Acronym

The impact of severe obesity on sleep apnea

Scientific Title

Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan

Scientific Title:Acronym

Study on the phenotype of sleep-disordered breathing in severe obese patients in Japan

Region

Japan


Condition

Condition

Sleep-disordered breathing

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To see the clinical differences between patients with and without diurnal and/or nocturnal hypercapnia in severe obese patients with suspected sleep-disordered breathing.

Basic objectives2

Others

Basic objectives -Others

To compare the early adherence and the symptoms improvement in patients who initiated continuous positive pressure (CPAP) therapy.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

symptoms, physical findings, lung function, biochemistry, cardiac echo (if possible), polysomonographic findings, and the prevalence of obesity hypoventilation, sleep hypoventilation and typical obstructive sleep apnea.

Key secondary outcomes

CPAP level, adherence, the change of sleepness(ESS), and drop-out rate


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

1. Severe obesity patients (Body mass index(BMI) >= 35kg/m2)
2. Patients with suspected sleep apnea

Key exclusion criteria

Patients with
1. uncontrollable congestive heart failure
2. psychiatric disease under treatment
3. respiratory failure on oxygen
4. undesirable patients judged by doctors
and
5. patients without informed consents

Target sample size

96


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Nakayama

Organization

Neuropsychiatric Research Institute

Division name

Japan Somnology Center

Zip code

1510053

Address

Yoyogi 5-10-10, Shibuya-ku, Tokyo, JAPAN

TEL

0334603033

Email

hidenaka@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Nakayama

Organization

Neuropsychiatric Research Institute

Division name

Japan Somnology Center

Zip code

1510053

Address

Yoyogi 5-10-10, Shibuya-ku, Tokyo, JAPAN

TEL

0334603033

Homepage URL


Email

hidenaka@tokyo-med.ac.jp


Sponsor or person

Institute

Neuropsychiatric Research Institute

Institute

Department

Personal name



Funding Source

Organization

TEIJIN PHARMA LIMITED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Neuropsychiatric Research Institute

Address

Bentencho 91, Shinjuku-ku, Tokyo, JAPAN

Tel

0302609171

Email

nakayama@somnology.com


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

2020 Year 09 Month 15 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

Enrolling by invitation

Date of protocol fixation

2020 Year 08 Month 17 Day

Date of IRB

2020 Year 08 Month 14 Day

Anticipated trial start date

2020 Year 09 Month 15 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 09 Month 15 Day

Last modified on

2022 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047624


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name