UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031411
Receipt number R000035869
Scientific Title Evaluation of sleep quality improvement by breathing for primary caregivers of elderly people with dementia at home
Date of disclosure of the study information 2018/05/01
Last modified on 2023/02/28 08:36:34

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Basic information

Public title

Evaluation of sleep quality improvement by breathing for primary caregivers of elderly people with dementia at home

Acronym

Evaluation of sleep quality improvement by breathing for primary caregivers of elderly people with dementia at home

Scientific Title

Evaluation of sleep quality improvement by breathing for primary caregivers of elderly people with dementia at home

Scientific Title:Acronym

Evaluation of sleep quality improvement by breathing for primary caregivers of elderly people with dementia at home

Region

Japan


Condition

Condition

Main caregiver of elderly with dementia at home

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is to clarify the evaluation of quality improvement of sleep by breathing method from the subjective index to the main caregiver of elderly people with dementia at home.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pittsburgh Sleep Questionnaire Japanese
version
OSA sleep survey form MA version
sleeping diary

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

breathing mehtod

Interventions/Control_2

no breathing mehtod

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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Cared person has dementia with dementia or non-cancer disease
The state of the care receiver is stable
Primary caregiver has appeal of sleep disorder
The primary caregiver has no mental disorder
The primary caregiver has no cardiovascular and respiratory disease








Key exclusion criteria

Does not satisfy selection criteria

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuka
Middle name
Last name Kondo

Organization

Gunma University Graduate School

Division name

Health Sciences Department of Nursing

Zip code

371-8511

Address

Maebashi Gunma

TEL

027-220-7111

Email

yukondo@gunma-u.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Kondo

Organization

Gunma University Graduate School

Division name

Health Sciences Department of Nursing

Zip code

371-8511

Address

Maebashi Gunma

TEL

027-220-7111

Homepage URL


Email

yukondo@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Research grant by the Japan Society of Nursing Research Association

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

Gunma,University

Address

Maebashi City,Gunma

Tel

0272207111

Email

yukondo@gunma-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

2018 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

6

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

Completed

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2018 Year 04 Month 04 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2022 Year 04 Month 30 Day

Date of closure to data entry

2023 Year 02 Month 28 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 22 Day

Last modified on

2023 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035869


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name