UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046122 |
|---|---|
| Receipt number | R000052642 |
| Scientific Title | The effects of olfactory stimulation during REM sleep on brain potential |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/05/21 23:08:02 |
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Basic information
Public title
The effects of olfactory stimulation during REM sleep on brain potential
Acronym
The effects of olfactory stimulation during REM sleep on brain potential
Scientific Title
The effects of olfactory stimulation during REM sleep on brain potential
Scientific Title:Acronym
The effects of olfactory stimulation during REM sleep on brain potential
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim is to reveal physiological responses of presentation of familiar odor during REM sleep for understanding the phenomenon, "Familiar odor induces negative dream emotion during REM sleep (Okabe et al., 2020)".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-REM negativity (PRN; Abe et al., 2008), the negative potential occurring prior to rapid eye movement, at Fpz electrode
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Phenylethyl alcohol (rose-like odor) will be presented at REM sleep during nocturnal sleep at sleep chamber of laboratory, as odor condition. At a later day, odorless stimuli will be also presented as control condition. The effect of odor on brain potential will be obtained by comparison between control and odor condition.
Interventions/Control_2
Odorless stimuli will be presented at REM sleep during nocturnal sleep at sleep chamber of laboratory, as control condition. At a later day, Phenylethyl alcohol (rose-like odor) will be also presented as odor condition. The effect of odor on brain potential will be obtained by comparison between control and odor condition.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) They do not have difficulty in filling out Japanese explanatory documents, consent forms, and survey forms.
2) They can stay in the sleep chamber of human sleep laboratory, WPI-IIIS, University of Tsukuba.
3) They have no sleep disorder, olfaction/taste disorder and no history.
4) Their subjective rating of phenylethyl alcohol is familiar odor.
"Familiar" is defined as rating as 8 or 9 points, on the scale of "know very little (1 point)" to "neither (5 points)" to "very familiar (9 points)".
Key exclusion criteria
1) Persons with claustrophobia
2) Women who are or may be pregnant
3) Lactating women
4) Patients who may have sudden changeable sickness or have a history
5) Any other person judged by the investigator to be inappropriate as a subject
* The above is set for safety considerations.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-859-1469
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Okabe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-859-1469
Homepage URL
satomiokabe.experiment@gmail.com
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Neurological Research Institute
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
jisedai@md.tsukuba.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R03-040
Org. issuing International ID_1
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
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 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052642
