UMIN-CTR Clinical Trial

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
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	029-859-1469
Homepage URL
Email	satomiokabe.experiment@gmail.com

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	Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	029-853-3914
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052642