UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051485 |
|---|---|
| Receipt number | R000055902 |
| Scientific Title | The effects of odor presentation during REM sleep on dream emotionality |
| Date of disclosure of the study information | 2023/06/29 |
| Last modified on | 2023/06/29 22:34:41 |
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Basic information
Public title
The effects of odor presentation during REM sleep on dream emotionality
Acronym
The effects of odor presentation during REM sleep on dream emotionality
Scientific Title
The effects of odor presentation during REM sleep on dream emotionality
Scientific Title:Acronym
The effects of odor presentation during REM sleep on dream emotionality
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of odor presentation on dreaming during REM sleep and associated brain activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amygdala activitiy during REM sleep estimated from EEG
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
1: Pre-exposure sleep experiment. Phenylethyl alcohol (rose-like odor) will be presented during nocturnal sleep at a sleep chamber of laboratory. 2: Repeted exposure for Phenylethyl alcohol to induce mere-exposure effect during daytime experment. 3: Post-exposure sleep experiment. The protocol is same as pre-exposure sleep experiment.
Interventions/Control_2
1: Pre-exposure sleep experiment. Phenylethyl alcohol (rose-like odor) will be presented during nocturnal sleep at a sleep chamber of laboratory. 2: Repeted exposure for Eugenol (clove like odor) to induce mere-exposure effect during daytime experment. 3: Post-exposure sleep experiment. The protocol is same as pre-exposure sleep experiment.
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) Subjective ratings on 1-9 scales of Phenylethyl alcohol and Eugenol at screening are as follows: preference is middle (3-7 points), familiarity is low (<=6 points).
2) 20<= and 25>= years old.
3) No sleep disorder, olfaction/taste disorder and no history.
4) No sleep disorder was susupected by PSG at adaptation night.
5) Not taking medications that affect sleep, olfaction/taste.
Key exclusion criteria
1) Having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms.
2) Who cannot stay in the sleep chamber of National center of neurology and psychiatry.
3) Who have specific episodic memory about Phenylethyl alcohol and eugenol, confirmed at screening.
4) No improvement of preference and familiarity ratings through odor exposure.
5) Persons at high risk person developing dermatitis due to experimental equipments or alcohol cotton for attach the electrodes.
6) Persons with claustrophobia.
7) Patients who may have sudden changeable sickness or have a history.
8) Patients who have mental disorders diagnosis/treatment or have a history.
9) Women who are or may be pregnant.
10) Lactating women.
11) Any other person judged by the investigator to be inappropriate as a subject.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of sleep-wake disorders, National institute of mental health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-346-2071
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Okabe |
Organization
National Center of Neurology and Psychiatry
Division name
Department of sleep-wake disorders, National institute of mental health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-346-2014
Homepage URL
satomiokabe.experiment@gmail.com
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology
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
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
Tel
042-341-2712
rinri-jimu@ncnp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
A2022-057
Org. issuing International ID_1
Ethics Committee, National Center of Neurology and Psychiatry
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 29 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | 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
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055902
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