UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055417 |
|---|---|
| Receipt number | R000063253 |
| Scientific Title | An exploratory study of the effects of a pseudo-heartbeat generating device on sleep. |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/09/04 16:45:42 |
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Basic information
Public title
An exploratory study of the effects of a pseudo-heartbeat generating device on sleep
Acronym
An exploratory study of the effects of a pseudo-heartbeat generating device on sleep.
Scientific Title
An exploratory study of the effects of a pseudo-heartbeat generating device on sleep.
Scientific Title:Acronym
An exploratory study of the effects of a pseudo-heartbeat generating device on sleep.
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we will evaluate the effects of a quasi-heart rate generating device (Q-chan) on sleep using a wearable device to evaluate objective sleep indices and Heart Rate Variability (HRV). The purpose of this study is to explore the relationship between the autonomic nervous system and sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SOL on day 5 using a wearable device (wristwatch-type activity meter) with photoplethysmography (PPG) (64 oscillations/minute, which has been reported to be effective in previous studies).
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The objective physiological index data such as HRV, SOL, SE, and sleep-wake rhythm before and after falling asleep will be collected using a wristwatch wearable device, and a questionnaire on subjective sleep will be administered. On days 1 and 2, Q-Chan was not used, and only the wristwatch-type wearable device was worn, and on days 3 to 7, the wristwatch-type wearable device was worn in the same manner. The subjects were asked to hold Q-chan in their hands at bedtime. On the second and subsequent days, participants were asked to respond to a questionnaire sent by e-mail the next morning regarding their sleep on the previous day.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who meet all of the following criteria
a) between 18 and 65 years of age
b) Those who are in the borderline range of the Athens Insomnia Scale (total: 1 to 5 and Q1 is greater than 1)
c) Those who are capable of wearing and using a wearable device and operating the electronic Patient Reported Outcome (ePRO) input operation.
Key exclusion criteria
Persons who meet all of the following criteria
a) Patients with chronic diseases such as hypertension, diabetes mellitus, hyperlipidemia, sleep apnea syndrome, and psychiatric disorders who are being treated as outpatients.
b) Persons who are judged to be unsuitable by the principal investigator
c) Persons who have withdrawn their consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Takaesu |
Organization
University of the Ryukyus
Division name
Lecture on Psychiatry, Graduate School of Medicine
Zip code
903-0215
Address
207 Aza-Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL
098-895-1157
takaesuy@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Takaesu |
Organization
University of the Ryukyus
Division name
Lecture on Psychiatry, Graduate School of Medicine
Zip code
903-0215
Address
207 Aza-Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL
098-895-1157
Homepage URL
takaesuy@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
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
Ethics Review Committee for Life Sciences and Medical Research Involving Human Subjects, University of the Ryukyus
Address
207 Aza-Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
Tel
098-895-1542
krinken@acs.u-ryukyu.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
| 2024 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063253
