UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029820 |
|---|---|
| Receipt number | R000034068 |
| Scientific Title | A study of the physiological monitoring at home for insomnia disorder in cancer patients |
| Date of disclosure of the study information | 2017/11/04 |
| Last modified on | 2022/05/09 09:28:59 |
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Basic information
Public title
A study of the physiological monitoring at home for insomnia disorder in cancer patients
Acronym
A monitoring at home for insomnia disorder
Scientific Title
A study of the physiological monitoring at home for insomnia disorder in cancer patients
Scientific Title:Acronym
A monitoring at home for insomnia disorder
Region
| Japan |
Condition
Condition
Insomnia disorder
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Construction of a self-care system in which cancer patients with insomnia disorder perform heart rate variability biofeedback therapy at home
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A change in sleep efficiency, sleep latency, and heart rate variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Device,equipment |
Interventions/Control_1
Interventions group: heart rate variability biofeedback at home
Duration: 2 weeks
Interventions/Control_2
Contorl group: No treatment at home
Duration: 2 weeks
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
Cancer patients with sleep disturbance
Key exclusion criteria
Secodary insomnia
Uncontrolled psychiatric disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medeical Univesity
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant within the Kansai Medical University
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
Kansai Medical University
Address
Shinmachi 2-5-1, Hirakata, Osaka
Tel
072-804-0101
h.hasuo7@gmail.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
| 2017 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000053496
Publication of results
Published
Result
URL related to results and publications
https://spcare.bmj.com/content/early/2020/09/20/bmjspcare-2020-002324.long
Number of participants that the trial has enrolled
50
Results
A home practice of HRV-BF with resonant breathing made it possible to acquire its techniques early on and improve sleep and autonomic function; therefore, our study showed high short-term efficacy and feasibility required for a self-coping system.
Results date posted
| 2022 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study participants were incurable cancer patients with sleep disturbance (aged 20 years and older) who underwent hospital-based HRV-BF sessions.
Participant flow
One (home HRV-BF group) and 2 study participants (control group) discontinued between day 7 and 14 (completion rates: 96.0% in home HRV-BF group and 92.0% in control group).
Adverse events
Adverse events caused by the HRV-BF with resonant breathing, were not observed.
Outcome measures
The rate of change in sleep efficiency for 10-14 days was considered as a primary endpoint.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034068
