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Trial registered on ANZCTR


Registration number
ACTRN12619001598178
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
20/11/2019
Date last updated
28/01/2022
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the health effects of one month of simulated wind farm infrasound: A community-based randomised controlled trial.
Scientific title
Assessing the health effects of one month of simulated wind farm infrasound: A community-based randomised controlled trial
Secondary ID [1] 299116 0
Australian NH&MRC Targeted Call for Research Grant Grant APP113615
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disturbance 314170 0
Wind Turbine Syndrome 314171 0
Condition category
Condition code
Neurological 312538 312538 0 0
Studies of the normal brain and nervous system
Mental Health 313413 313413 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of two groups. One group exposed to one month of continuous infrasound speaker exposure and the other group exposed to sham (no sound) speaker exposure. The key exposure of windfarm simulated infrasound at 93dB pK (test exposure) will be generated by specially manufactured speaker boxes which will be placed in each of the participants’ bedrooms and will operate continuously for the duration of the study. Microphones continuously monitor the presence and level of infrasound in the bedroom for the duration of the study.
Intervention code [1] 315388 0
Other interventions
Comparator / control treatment
No added sound (sham, negative control). Speaker boxes identical to the infrasound generating boxes used for the wind farm exposure will be placed in the participants’ bedrooms.
Control group
Placebo

Outcomes
Primary outcome [1] 321187 0
Changes in wake after sleep onset (WASO) as determined by 4 EEG channel polysomnography with the Alice PDx portable recorder, This will be defined using standard electroencephalography (EEG) based criteria. We will compare the effects of infrasound and sham.
Timepoint [1] 321187 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement. The primary timepoint will be the 1 month measurement.
Secondary outcome [1] 374219 0
Sleep latency (Time to onset of 1st sleep at night as determined by a polysomnography)
Timepoint [1] 374219 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement.
Secondary outcome [2] 374220 0
Sleep Stage Shifts (The total number of sleep stage transitions over the whole night as determined by a polysomnography)
Timepoint [2] 374220 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement.
Secondary outcome [3] 374221 0
Sleep staging (A measure of sleep architecture using the proportions of recorded sleep time that are scored as being stage 1 2 3 or REM sleep as recorded on a polysomnography)
Timepoint [3] 374221 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement.
Secondary outcome [4] 374222 0
Arousal frequency (the Arousal Index is a measure of the number or cortical arousals captured via the EEG on a polysomnography per hour of scored sleep)
Timepoint [4] 374222 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement.
Secondary outcome [5] 374223 0
Power spectral analysis for sleep microarchitecture analysis

Quantitative EEG analysis techniques will be applied to all sleep EEG signals from polysomnography recordings after identification and exclusion of artefacts. Sleep stage specific power spectra using a fast Fourier transform routine and scaling exponents from detrended fluctuation analysis will be quantified. Sleep spindle characteristics including density (no. of spindles/min of NREM), duration, and morphology (frequency, amplitude and symmetry), and dynamics of slow wave activity (SWA) across the night will also be computed. The topographical and regional distribution of sleep EEG oscillations (i.e. SWA, K- complexes and sleep spindles) will be examined to detect changes in cortical activity across key brain regions that may occur from the study interventions. EEG data will be collected using established data acquisition processes using hospital approved sleep recording systems in the sleep laboratory. Analysis of EEG data will be performed through internally developed and validated software as well as PhiTools PRANA software.
Timepoint [5] 374223 0
Single overnight polysomnography study will be measured 1 month after the initial baseline measurement.
Secondary outcome [6] 374224 0
Sleep parameters measured by actigraphy
Timepoint [6] 374224 0
At 1 month after the initial baseline measurement.
Secondary outcome [7] 374225 0
Neurocognitive test (n-back score and Tower of London score)
Timepoint [7] 374225 0
At 1 month after the initial baseline measurement.
Secondary outcome [8] 374226 0
Insomnia Severity Index (ISI) score (range: 0 to 28)
Timepoint [8] 374226 0
At 1 month after the initial baseline measurement.
Secondary outcome [9] 374227 0
Epworth Sleepiness Scale (ESS) score (range: 0 to 24)
Timepoint [9] 374227 0
At 1 month after the initial baseline measurement.
Secondary outcome [10] 374228 0
Noise Annoyance Visual Analog Scale (range: 0 to 10)
Timepoint [10] 374228 0
At 1 month after the initial baseline measurement.
Secondary outcome [11] 374229 0
General Health Symptoms Visual Analog Scale (range: 0 to 10)
Timepoint [11] 374229 0
At 1 month after the initial baseline measurement.
Secondary outcome [12] 374230 0
Kessler 10 (K10) score (range: 10 to 50)
Timepoint [12] 374230 0
At 1 month after the initial baseline measurement.
Secondary outcome [13] 374231 0
Depression, Anxiety and Stress Scale (DASS-21) score (range: 0 to 42 depression, anxiety and stress)
Timepoint [13] 374231 0
At 1 month after the initial baseline measurement.
Secondary outcome [14] 374232 0
Warwick Edinburgh Mental Wellbeing Scale score (range: 14 to 70)
Timepoint [14] 374232 0
At 1 month after the initial baseline measurement.
Secondary outcome [15] 374234 0
Anthropometric measures - Body Mass Index by portable stadiometer for the height component and by portable digital scale for the weight component
Timepoint [15] 374234 0
At 1 month after the initial baseline measurement.
Secondary outcome [16] 374235 0
Blood Pressure (mmHg) by portable digital self-inflating sphygmomanometer
Timepoint [16] 374235 0
Average of 3 measurements taken at 1 month after the initial baseline measurement.
Secondary outcome [17] 374236 0
Arterial Stiffness - Pulse Wave Velocity (m/s)
Timepoint [17] 374236 0
At 1 month after the initial baseline measurement.

Eligibility
Key inclusion criteria
1. Aged 18 or above
2. Noise sensitive individuals -defined as Weinstein’s Noise Sensitivity Scale (WNS) Score >58 (which was the median score in a reported study)
3. Normal hearing based on phone questionnaire
4. Regular sleep of minimum 5.5 hours / 24 hours for 7 days as demonstrated by 1 week of actigraphy
5. Fluent in English, to be able to answer computerised questionnaires and undergo neurocognitive assessments in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Rotating shift worker
2. Planning to be away from home during the study period
3. Major psychiatric disorders
4. Use of any hypnotic medications or other medications that interfere with sleep within the last month
5. Anyone in the household pregnant or breastfeeding or planning to during the study period
6. Children younger than 5 years of age living or regularly spending time in the home.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Secure randomisation will be achieved through Research Tools(TM) by entering secure participant data in order to access a unique participant randomisation number. The unique participant number will be assigned in ascending chronological order. Screening of suitable participants will be undertaken in three phases. The first phase will be done over the phone to check if the participant has normal hearing and does not wear a hearing aid. The second phase will be conducted via an online screening questionnaire. The third phase will combine a non- invasive technique (wrist actigraphy and sleep diary) for the at-home measurement of normal sleep/wake cycles.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned the type of exposure (infrasound speaker or sham speaker) in a random order. A statistician who assists the Data Safety Monitoring Board (DSMB) and who will never meet any participant or play role in selection or testing of participants has computer generate the randomisation list in blocks of 12, with 12 blocks of 12 = 144 randomisation numbers..
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Expectations on the part of participants and investigators may influence the effect of the exposure (infrasound) and, more particularly, may influence the measurement of those effects, especially the subjective (self-reported) outcomes. To avoid the potential for this measurement bias, it is important that both participants and the investigators who are measuring outcomes are blinded to the intervention group. Fortunately, as infrasound is, by definition, inaudible, this is readily achieved by the use of a sham device that appears the same as the infrasound device, but which does not produce any sound. Only the unblinded acoustic engineer will have knowledge of the exposure and they will never meet a participant.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Generalised linear mixed models will be utilised for statistical analysis. WASO will be the dependent variable in the primary analysis. All other outcomes will be tested separately as dependent variables. Exposure (infrasound vs sham) will be the main fixed effect. As multiple outcome measures will be made (at baseline and at 1 month follow-ups) a “time” fixed effect will also be included and exposure-by- time interactions will be tested. The differences specifically at the 1 month time period will be the primary endpoint. In sub-analyses we will also test whether changes in outcomes are influenced by whether people thought windfarms have health effects (expectancy) to establish whether this attribute modifies the propensity to experience WTS symptoms with exposure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2019
Actual
9/12/2019
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
120
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303658 0
Government body
Name [1] 303658 0
NHMRC
Country [1] 303658 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road Glebe 2037
NSW
Country
Australia
Secondary sponsor category [1] 303749 0
None
Name [1] 303749 0
Address [1] 303749 0
Country [1] 303749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304178 0
Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital Zone)
Ethics committee address [1] 304178 0
Ethics committee country [1] 304178 0
Australia
Date submitted for ethics approval [1] 304178 0
09/07/2019
Approval date [1] 304178 0
24/07/2019
Ethics approval number [1] 304178 0
X17-0235 and HREC/17/RPAH/351

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96054 0
Prof Guy Marks
Address 96054 0
Woolcock Institute of Medical Research 431 Glebe Point Road
Glebe
NSW 2037
Country 96054 0
Australia
Phone 96054 0
+61 2 9114 4066
Fax 96054 0
+61 2 9114 0011
Email 96054 0
guy.marks@sydney.edu.au
Contact person for public queries
Name 96055 0
Brett Toelle
Address 96055 0
Woolcock Institute of Medical Research 431 Glebe Point Road
Glebe
NSW 2037
Country 96055 0
Australia
Phone 96055 0
+61 2 9114 4062
Fax 96055 0
+61 2 9114 0011
Email 96055 0
brett.toelle@sydney.edu.au
Contact person for scientific queries
Name 96056 0
Brett Toelle
Address 96056 0
Woolcock Institute of Medical Research 431 Glebe Point Road
Glebe
NSW 2037
Country 96056 0
Australia
Phone 96056 0
+61 2 9114 4062
Fax 96056 0
+61 2 9114 0011
Email 96056 0
brett.toelle@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data collected during the trial
When will data be available (start and end dates)?
Data will be available from date of publication of the main report and for 10 years from the date of publication.
Available to whom?
Researchers who provide a scientifically valid and ethically approved protocol
Available for what types of analyses?
Available for analyses contained within an ethically approved protocol
How or where can data be obtained?
Data will be provided to the researcher directly by the Principal Investigator, Professor Guy Marks subject to receipt of the ethics approval and the ethically approved protocol. Email Address: guy.marks@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4299Study protocol    ANZCTR 378249-(Uploaded-23-10-2021-13-18-25)-Study-related document.pdf
4300Informed consent form    378249-(Uploaded-23-10-2021-13-21-28)-Study-related document.pdf
4301Ethical approval    378249-(Uploaded-29-10-2019-14-27-04)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.