None listed
Conditions
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.)
Interventions
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 dev
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.
Sponsors
Professor Yuan Miao
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed