UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039772 |
|---|---|
| Receipt number | R000044746 |
| Scientific Title | The effect of olfactory stimulation during REM sleep on dreams |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2021/09/11 13:35:37 |
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Basic information
Public title
The effect of olfactory stimulation during REM sleep on dreams
Acronym
The effect of olfactory stimulation during REM sleep on dreams
Scientific Title
The effect of olfactory stimulation during REM sleep on dreams
Scientific Title:Acronym
The effect of olfactory stimulation during REM sleep on dreams
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of olfactory stimulation during REM sleep on dreams.
Previous studies have shown that olfactory stimulation during REM sleep induced negative dreams when the subjects like the odor (Okabe et al., 2018) or are familiar with it (Okabe et al., 2020).
In this study, we focused on the intensity. We will consider whether the effect of odor on dreams is different between the 2 groups divided as how intense the odor is perceived subjectively.
We hypothesized that the odor would induce negative dreams only for the subjects whose impression of odors are strong, because both favor and high-familiarity of odors were associated with feeling odor more strongly (Distel et al., 1999).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Emotionality of dreams
Subjects will rate their own dreams with the Dream property scale (Takeuchi et al., 1996), at awakenings after odor presentation during REM sleep.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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 during subjects' REM sleep. After the presentation, subjects will be awaken and rate their dream emotionality.
For the same subjects, at same night, only airflow without any odor will be also presented as control condition.
The effect of odor on dreams will be obtained by comparison between control and odor condition.
The order of each conditions will be counterbalanced.
Also, we will compare the effect of odor on dreams between the groups that selected by preceding screening test. One group (Interventions 1) is high group, consisting of subjects who have the impression that the phenylethyl alcohol odor is strong.
Interventions/Control_2
The other group (Interventions 2) is low group, consisting of subjects who have the impression that the phenylethyl alcohol odor is weak.
The protocol is same as interventions 1 (high group).
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 subjectively rating of phenylethyl alcohol odor is strong or weak, deviating from average.
* In the screening, the impression of odor (subjective intensity, like/dislike, familiarity, etc.) will be evaluated on a 9-point scale that labeled "very weak (1 point)" to "neither (5 points)" to "strong (9 points)". Regarding the subjective intensity, rater of 1 to 3 points will be classified as "low group" and 6 to 9 points will be "high group".
This criterion had been determined using data from a total of 407 people (age range: 18 to 25 years) obtained from our previous studies (Okabe et al., 2018; 2020), as 1-3 points for weak group and 8-9 points for strong group. However, we predicted that we would not be able to obtain enough number of strong group when we got about 100 data at screening, so we modified the criteria of strong group to 6-9 points.
5) Their subjective rating of phenylethyl alcohol odor is moderate at favor and familiarity.
* Regarding favor, 3 to 6 points are "moderate", from the scale of "very dislike (1 point" to "neither (5 points)" to "very like (9 points)". Regarding familiarity, 4 to 7 points are "moderate", from 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
40
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
080-6256-4868
Homepage URL
s1930384@s.tsukuba.ac.jp
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
Tsukuba Clinical Research & Development Organization (T-CReDO)
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R01-141
Org. issuing International ID_1
Tsukuba Clinical Research & Development Organization (T-CReDO)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 15 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2021 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044746
