Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000275763
Ethics application status
Not yet submitted
Date submitted
4/03/2013
Date registered
7/03/2013
Date last updated
7/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Data Analysis on the Effects of Taxus Chinensis Scent on Sleeping Quality of People with High Blood Pressure
Scientific title
Data Analysis on the Effects of Taxus Chinensis Scent on Sleeping Quality of People with High Blood Pressure
Secondary ID [1] 282061 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleeping disorders 288548 0
Hypertension 288580 0
Condition category
Condition code
Alternative and Complementary Medicine 288875 288875 0 0
Herbal remedies
Cardiovascular 288876 288876 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pillow with Taxus chinensis extract (smells similar to tea) infill (cross-over at the middle of the study, after two weeks break) will be provided for participants to use during their sleep for three weeks.

Each participant will be provided with a mobile device, which has an embedded accelerometer and microphone to record the body movement and the volume of breathing sound during their sleep. Participants will be automatically promoted by a special designed software embedded in the mobile device to record movement and sound volume during the night. The smart phone will be placed close to the body during sleep and will only switch on network during day time to transfer the data. Participants have an option to use it as their primary phone during the study. Participants will also be asked to answer a set of questions on general well-being, sleeping quality, diet and physical activities at pre and post of each intervention, for analysis.
Intervention code [1] 286659 0
Treatment: Other
Comparator / control treatment
A pillow with placebo (tea) infill (cross-over at the middle of the study, after two weeks break) will be provided for participants to use during their sleep for three weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 289005 0
It is anticipated that this study will discover the details of how Taxus chinensis aromatic therapy improves the participants’ sleeping quality.

The participants' body movement and breathing sound volume (not to record to the actual sound) will be automatically recorded by the mobile device during their sleep. The Pittsburgh Sleep Quality Index (PSQI) is to be used as a self-rated questionnaire which assesses sleep quality and disturbances, at pre, mid (when crossover) and post trial to assess the effects.
Timepoint [1] 289005 0
The outcomes will be measured and analysed at the end of each phase of the trail, ie. when the interventions (treatment and control group) crossover (week 4) and at the end of the trial (week 8).
Primary outcome [2] 289006 0
It is anticipated that this study will discover the details of how Taxus chinensis aromatic therapy improves the participants’ general well-being.

Physical and psychological well-being will be investigated by the Short Form 36 Health Survey (SF-36), and a questionnaire to record participants' diet and physical activity levels will be used, and participants' blood pressure will be measured by the researcher, at pre, mid (when crossover) and post trial to assess the effects.
Timepoint [2] 289006 0
The outcomes will be measured and analysed at the end of each phase of the trail, ie. when the interventions (treatment and control group) crossover (week 4) and at the end of the trial (week 8).
Secondary outcome [1] 301551 0
Nil
Timepoint [1] 301551 0
Nil

Eligibility
Key inclusion criteria
- has lived in Australia for the past 10 years

- has used smart phone and feels comfortable to use it

- aged 45-75 years and with moderate hypertension (blood pressure lower than 159/99 mmHg)

- has sleeping disorders in the past three month or longer, and
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- acute respiratory infections, olfactory (sense of smell) disorders or nasal blockage

- has other major medical conditions (ie. established CVD, severe diabetes, thyroid dysfunction, asthma, hepatic or renal disorders) or pregnancy / lactation

- has taken other supplements or medicine which may influence blood pressure in the past three months, or has taken blood pressure management tablet in a same dosage and has not changed within the past three month

- allergic to the extract of Taxus chinensis and its scent (this also applies to their family members who could have access to the smell)

- has taken sleeping tablets, supplements or medicine which may influence sleeping

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher who is familiar with this type of clinical trial will be invited as the third party to label the treatment and placebo pillow (which will be packed the same). The pillow is assigned to match the participants’ codes and groups (i.e. A1, A2... or B1, B2...; names will be kept confidential). This researcher will be asked not to reveal relevant information to either researchers or participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be grouped based on a random number table. Participants in Group A will receive the treatment of the Taxus chinensis extract scent pillow for the first three weeks while participants in Group B will receive the placebo during the same period. After two weeks of the wash out period (break), for the second three weeks, the interventions will be switched, i.e. Group B will receive the Taxus chinensis extract scent pillow and Group A use placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed through the application of paired t-test using a software program SPSS 18.0 to determine the following:
- The difference between Group A and Group B before treatment commenced.
- The difference between pre- and post-intervention results for all the participants in both groups, i.e. in the first three weeks with Group A as the treatment group and Group B as the control group, and in the second three weeks with Group B as the treatment group and Group A as the control. Pre- and post- treatment effects were also considered for the combination of Group A and B. P < 0.05 was accepted as significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
1/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286838 0
Commercial sector/Industry
Name [1] 286838 0
Zhangguang 101 Holding Group
Country [1] 286838 0
China
Primary sponsor type
University
Name
Professor Yuan Miao
Address
School of Engineering and Science
Victoria University
PoBox 14428 Melbourne
Vic 8001
Country
Australia
Secondary sponsor category [1] 285627 0
None
Name [1] 285627 0
Address [1] 285627 0
Country [1] 285627 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288904 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 288904 0
Victoria University
PoBox 14428, Melbourne
Vic 8001
Ethics committee country [1] 288904 0
Australia
Date submitted for ethics approval [1] 288904 0
29/01/2013
Approval date [1] 288904 0
Ethics approval number [1] 288904 0
HRE13-027

Summary
Brief summary
Submitted on 29 Jan, 2013, [Dr. Deborah Zion, the Chair of the Victoria University Human Research Ethics Committee informed this ANZCTR is required before final approval is given.] (Office for Research, Victoria University, PO Box 14428, Melbourne, VIC, 8001 or phone (03) 9919 4781.)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38274 0
Prof Yuan Miao
Address 38274 0
School of Engineering and Science
Victoria University
PO Box 14428
Melbourne, Vic 8001
Country 38274 0
Australia
Phone 38274 0
+61 3 99194605
Fax 38274 0
Email 38274 0
[email protected]
Contact person for public queries
Name 38275 0
Yuan Miao
Address 38275 0
School of Engineering and Science
Victoria University
PO Box 14428
Melbourne, Vic 8001
Country 38275 0
Australia
Phone 38275 0
+61 3 99194605
Fax 38275 0
Email 38275 0
[email protected]
Contact person for scientific queries
Name 38276 0
Yuan Miao
Address 38276 0
School of Engineering and Science
Victoria University
PO Box 14428
Melbourne, Vic 8001
Country 38276 0
Australia
Phone 38276 0
+61 3 99194605
Fax 38276 0
Email 38276 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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