UMIN-CTR Clinical Trial

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
Email	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
Email	s1930384@s.tsukuba.ac.jp

Sponsor
Institute	International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044746