UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052635 |
|---|---|
| Receipt number | R000060052 |
| Scientific Title | Influence of tea aroma on sleep and stress in asthmatic patients -cross-over study- |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/30 19:03:22 |
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Basic information
Public title
Influence of tea aroma on sleep and stress in asthmatic patients -cross-over study-
Acronym
Influence of tea aroma on sleep and stress in asthmatic patients
Scientific Title
Influence of tea aroma on sleep and stress in asthmatic patients -cross-over study-
Scientific Title:Acronym
Influence of tea aroma on sleep and stress in asthmatic patients
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the Effect of Tea Fragrance on Sleep and Stress in asthma patient
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Epwards drowsiness scale
Athens Insomnia Scale
Pittsburgh Sleep Scale
microtag activity meter
SCL30
SF-36
SDS
salivary chromogranin
Key secondary outcomes
Asthma Control Test
Feno
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
| Food |
Interventions/Control_1
During the first 2 weeks of Period I, the patients will be exposed to tea-scented water for 3 hours a day when they fall asleep using a diffuser. Placebo (water) will be diffused and volatilized when the patient falls asleep 3 hours a day for 2 weeks in Period II
Interventions/Control_2
During the first 2 weeks of Period I, placebo (water) will be diffused and volatilized when the subjects fall asleep 3 hours a day. During the second 2 weeks of Period II, the patients will be exposed to tea-scented water for 3 hours a day when they fall asleep using a diffuser.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with bronchial asthma
2.Patients who have given written consent for the study
Key exclusion criteria
1.Patients with tea allergy
2.Patients scheduled for hospitalization
3.Patients diagnosed with dementia
4.Patients currently participating in other clinical studies
5.Patients deemed inappropriate by the attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Otsubo |
Organization
Saga University
Division name
Department of lifelong developmental nursing
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
TEL
0952-34-2559
tsubomi@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Otsubo |
Organization
Department of Nursing, Saga University School of Medicine
Division name
Department of lifelong developmental nursing
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
TEL
0952342559
Homepage URL
tsubomi@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
Tel
0952343357
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
佐賀大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
not clear
Publication of results
Unpublished
Result
URL related to results and publications
http://jsa72.umin.jp/
Number of participants that the trial has enrolled
21
Results
There were 18 patients with good asthma control.Initial sleep evaluation showed that insomnia was suspected (6 points or higher) in 9 patients. 8 people had problems (scores of 6 or more).The microtag activity meter showed that those who volatilized black tea scented water had a total sleep time of 35 minutes longer, sleep effectiveness increased by 8.3%, the number of mid-day awakenings decreased by 2.4 times, and sleep latency. The time was reduced by 15.1 minutes.
Results date posted
| 2023 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of the 18 participants (1male, 17female)
Participant flow
Respiratory physicians were asked to recruit and 21 agreed to participate. They were randomized and divided into two groups. A total of 18 subjects were included: 9 in the placebo-first group (water to tea-scented water) and 9 in the aroma-first group (tea-scented water to water).
Adverse events
None noted
Outcome measures
Sleep was assessed using objective measurements with a microtag activity meter, the Athens Insomnia Scale, and the Pittsburgh Sleep Questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 10 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060052
