UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045833
Receipt number R000051860
Scientific Title The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar
Date of disclosure of the study information 2021/10/26
Last modified on 2025/05/02 15:33:17

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Basic information

Public title

The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar

Acronym

The clinical trial by ultra-wideband radar

Scientific Title

The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar

Scientific Title:Acronym

The clinical trial by ultra-wideband radar

Region

Japan


Condition

Condition

patients with suspected sleep disordered breathing (SDB)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify accuracy for measuring respiratory and heart rates and respiratory events by UWB radar with smartphone, comparing the data with the parameters by polysomnography (PSG) or portable monitoring

Basic objectives2

Others

Basic objectives -Others

To verify the equivalence of respiratory and heart rates and respiratory events by UWB radar with smartphone and those by PSG or portable monitoring

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The equivalence of respiratory and heart rates and respiratory events (RE) by UWB radar with smartphone and those by PSG or portable monitoring.

Key secondary outcomes

Comparison of respiratory rate and respiratory events during sleep measured by between smartphone and PSG or portable monitoring.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Measurements of respiratory and heart rate by UWB radar with smartphone,PSG, or portable monitoring simultaneously.

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 who are suspected to have sleep disordered breathing (SDB)

Key exclusion criteria

1.Patients who were already diagnosed as sleep apnea syndrome and treated.
2. Physically disabled patients
3.Patients who refuse to participate in this trial
4.Patients who are judged as inappropriate candidates by the doctor.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Chin

Organization

Nihon University of Medicine

Division name

Department of Sleep Medicine and Respiratory Care Division of Sleep Medicine Department of Internal Medicine

Zip code

173-8610

Address

30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo

TEL

03-3972-8111

Email

chin.kazuo@nihon-u.ac.jp


Public contact

Name of contact person

1st name Mamiko
Middle name
Last name Hoshi

Organization

Graduate school of medicine, Nihon university

Division name

Respitory medicine

Zip code

173-8610

Address

30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo

TEL

03-3972-8111

Homepage URL


Email

mema21005@g.nihon-u.ac.jp


Sponsor or person

Institute

Nihon University of Medicine

Institute

Department

Personal name



Funding Source

Organization

1.Japan Agency for Medical Research and Development
2. KYOTO Industrial Support Organization 21

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Shinjuku Sleep and Respiratory Medicine Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University of Medicine

Address

30-1 Oyaguchi kamicho Itabashi-ku Tokyo

Tel

03-3972-8111

Email

med.itabashi.chiken@nihon-u.ac.jp


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

2021 Year 10 Month 26 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

2021 Year 10 Month 13 Day

Date of IRB

2022 Year 01 Month 12 Day

Anticipated trial start date

2022 Year 01 Month 20 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2026 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information

Prospective observational study

Research to determine usefulness and accuracy in measurements of respiratory and heart rates by ultra-wideband radar

Outcomes will be evaluated at
1) The first admission
2) The second admission


Management information

Registered date

2021 Year 10 Month 22 Day

Last modified on

2025 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051860