UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Neurological Research Institute

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

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

Date of disclosure of the study information

2020

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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