Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000213842
Ethics application status
Approved
Date submitted
1/12/2020
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Date results provided
3/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of electromagnetic field exposure on sleep quality in healthy adults.
Scientific title
Effect of ambient radiofrequency radiation on Sleep in Healthy Adults: A Double-Blind, Randomised, Crossover Pilot Study
Secondary ID [1] 303192 0
Nil
Universal Trial Number (UTN)
U1111-1223-2413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disturbance 310294 0
Condition category
Condition code
Neurological 317796 317796 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 4 week randomised, double-blind, placebo-controlled crossover pilot study in healthy adult men and women. Two conditions will be compared: exposure to a 2.45GHz pulse-modulated radiofrequency device that will be either active or inactive (sham). The radiofrequency device that will be used is a standard Uniden baby monitor (BW3000 model) with a frequency of 2.45GHz and a transmitting power of 15dB. Using the Gigahertz HF59B HF Analyser with UBB27 antenna (frequency range between 27MHz to 3.3GHz), the power density measured at the bedhead with the receiver unit one metre away varied between 2,200 and 7,070 uW/m2 with peak readings exceeding 19,999 uW/m2. The exposure condition order will be randomized and fully counterbalanced across participants. Double-blinding will be achieved by having the baby monitors programmed (activated or deactivated) by an independent consultant so no participant or researcher will be able to correctly identify the device status. A random code will be assigned to each monitor, and monitors will be provided sequentially to participants with the codes being changed in the second week to an active and deactivated (sham) monitor to ensure the opposite condition will be met.
Twenty healthy adults (18 to 56 years) will be recruited to participate in the study. The participants will be assessed for eligibility using the Participant Screening Questionnaire to ensure they comply with the exclusion and inclusion criteria. An assessment of their home will be conducted to explain the study, obtain written permission and to measure electromagnetic fields in their bedroom to ensure they do not interfere with the study results. The home will be assessed by building biologist - Nicole Bijlsma who is the principal investigator of the study.
The study will involve a baseline week (week 1), two intervention weeks (weeks 2 and 4) and a washout week (week 3). On the first day of the study, the investigator will conduct a home visit (of up to one hour) and explain how to complete the daily sleep diary and wear the Actiwatch which will be worn across the entire study period (except during bathing). A charger will be provided in weeks 2 or 3 of the study period to ensure the battery life is sufficient. On day seven of the first week, the investigator will conduct a house visit to demonstrate how to fit the sleep monitor (ZMachine) and heart rate monitor and to remind the participants to complete the PIRS_20 survey the following morning (8th day). Participants will be shown where to place the devices during the night and how to turn the units off upon waking. An easy-to-follow instruction booklet and YouTube video will be created by the investigator as a backup to enable participants to watch anytime during the study period. This procedure will be repeated on the seventh night of each week for four consecutive weeks and participants will be asked to undertake this approximately the same time of night for each sleep stage (four nights in total over the study period). On day 8, the investigator will pick up the monitors and download the data.
On day 1 in weeks 2 and 4 (intervention weeks which were double blinded), the receiver unit (a coded digital wireless baby monitor) will be installed by the researcher within one meter of the participants’ bedhead, and the associated sender unit (wireless camera) will be installed at the opposite end of the bedroom for seven consecutive nights. Both units will be plugged into a power socket to ensure battery life for the duration of the 7 days. The monitors will be picked up on day 8. Participants will be contacted via text on a regular basis across the study period to ensure compliance and to confirm they understand how to fit and use the devices. The investigator will conduct 8 visits to the participant’s home.
The washout period in week 3 will involve exactly the same measures as Week 1 – Baseline.

Intervention code [1] 312826 0
Treatment: Devices
Comparator / control treatment
The deactivated baby monitor will be acting as a sham/placebo group.
Control group
Placebo

Outcomes
Primary outcome [1] 307987 0
Severity of sleep disturbance measured using the Pittsburgh Insomnia Rating Scale 20
Timepoint [1] 307987 0
The Pittsburgh Insomnia Rating Scale 20 will be completed on the 8th day of each week (4 times in total ie days 8, 15, 22 and 29).
Secondary outcome [1] 389266 0
Cycles of activity and rest during sleep, as measured using wrist actigraphy with the Actiwatch'
Timepoint [1] 389266 0
Wrist actigraphy to be worn for 29 consecutive days except during bathing
Secondary outcome [2] 390306 0
Heart rate variability measured using a heart rate monitor
Timepoint [2] 390306 0
Heart rate monitor to be worn on the seventh night of each week (4 times in total ie days 7, 14, 21 and 28). Intervention
Secondary outcome [3] 390307 0
Polysomnography to be measured with Zmachine
Timepoint [3] 390307 0
Sleep monitor to be worn on the seventh night of each week (4 times in total ie days 7, 14, 21 and 28)

Eligibility
Key inclusion criteria
20 healthy adult participants will be recruited from the general population. Participants need to satisfy the following criteria:
• Healthy subjects without current sleep disturbance
• Live in a detached home
• Aged between 18 and 56
• Non-smokers
• English speaking and able to give written informed consent
• Willing to avoid digital devices at least one hour before bed
• Willing to go to bed and get up at approximately the same time over the study period.
• Willing to avoid stimulants late in the day
• Willing to abstain from caffeine and alcohol in the evenings during the intervention period (two weeks)
Minimum age
18 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are designed to exclude potential confounding factors that may impact on radiofrequency exposures, and/or physiological or metabolic function. Exclusion criteria includes:
o background of AC magnetic fields exceeds 1 mG or radiofrequencies fields exceeds 20 uW/m2 in the bedroom
o have a smart meter, meter panel or inverter on any of the walls of their bedroom
o need to use a cell phone during the night
o BMI greater than 30
o diagnosed with any chronic medical condition that affects sleep (i.e. current or previous sleep disorder, history of renal, cardiac, gastrointestinal, liver, skin, psychiatric disorders or respiratory -other than asthma not requiring continuous medication) or any other condition for which the subject is currently taking medications or in the opinion of the investigators would impede competence, compliance, or participation in the study.
o recent hospitalisation, surgery or antibiotic therapy
o taking any medications or supplements that may interfere with sleep
o pregnant or expect/attempting to become pregnant or impregnate
o peri-menopausal women with menopausal symptoms and irregular menstrual periods
o unable to give informed consent
o travelled across time zones two weeks before or during the study period
o night shift worker or history of night shift work for more than 2 years

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)
The exposure condition order will be randomized and fully counterbalanced across participants. A random code will be assigned to each monitor, and monitors will be provided sequentially to participants with the codes being changed in the second intervention week to an active and deactivated (sham) monitor to ensure the opposite condition was met.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was computer generated.
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
Crossover
Other design features
In a cross-over study, the intervention weeks (weeks 2 and 4) will be double blinded and will involve placing an active or deactivated 2.4G baby monitor within 1 meter of the participant’s bedhead for 7 consecutive nights. The baby monitors have been engineered so that the active and deactivated baby monitors are indistinguishable and only known by 3rd party (independent consultant), that will release info on active units at the end of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effect size estimates for the present study were based on the findings of Lustenberger et al. (2013) who found a significant decrease in sleep time following Radiofrequency Electromagnetic Field (RF-EMF) Pulses (Mean decrease 9.23 minutes, SD 13.6) (Lustenberger et al., 2013). Using this result to estimate effect size, a power calculation was conducted estimating a minimum sample of 20 participants with alpha = .05 and power of 80% (G*Power 3.1.9.2) (Faul, Erdfelder, Lang, & Buchner, 2007).

The Statistical Package for the Social Sciences software (SPSS Inc., Armonk, New York, USA) will be used for data analysis. Baseline demographic characteristics on categorical and continuous variables such as gender, BMI and age will be summarised. Exploratory analyses of the distributional characteristics of each of the outcome measures (eg. PIRS20, actigraphy data, EEG measures) will be completed to evaluate the distributions for normality, skewness and outliers. At the baseline assessment, all data across each outcome will be correlated to evaluate the magnitude of association between the measures. Repeated measures ANOVA with posthoc pairwise comparisons (Bonferroni) will be used to evaluate differences across the intervention phases of the study, with p < 0.05 being considered statistically significant.

Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G* Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior research methods, 39(2), 175-191.
Lustenberger, C., Murbach, M., Durr, R., Schmid, M. R., Kuster, N., Achermann, P., & Huber, R. (2013). Stimulation of the brain with radiofrequency electromagnetic field pulses affects sleep-dependent performance improvement. Brain Stimul, 6(5), 805-811. doi:10.1016/j.brs.2013.01.017

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2019
Date of last participant enrolment
Anticipated
Actual
17/02/2020
Date of last data collection
Anticipated
Actual
17/03/2020
Sample size
Target
20
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 24598 0
3000 - Melbourne
Recruitment postcode(s) [2] 24599 0
3134 - Ringwood
Recruitment postcode(s) [3] 24600 0
3108 - Doncaster
Recruitment postcode(s) [4] 24601 0
3153 - Bayswater
Recruitment postcode(s) [5] 24602 0
3132 - Mitcham
Recruitment postcode(s) [6] 24603 0
3130 - Blackburn
Recruitment postcode(s) [7] 24604 0
3131 - Nunawading
Recruitment postcode(s) [8] 24605 0
3113 - Warrandyte
Recruitment postcode(s) [9] 24606 0
3136 - Croydon
Recruitment postcode(s) [10] 24607 0
3114 - Park Orchards
Recruitment postcode(s) [11] 24608 0
3135 - Heathmont
Recruitment postcode(s) [12] 24609 0
3115 - Wonga Park
Recruitment postcode(s) [13] 24610 0
3095 - Eltham

Funding & Sponsors
Funding source category [1] 301100 0
University
Name [1] 301100 0
RMIT University
Country [1] 301100 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
GPO Box 2476,
Melbourne VIC 3001
Australia.
Country
Australia
Secondary sponsor category [1] 300710 0
None
Name [1] 300710 0
Address [1] 300710 0
Country [1] 300710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301851 0
RMIT Human Research Ethics Committee (HREC).
Ethics committee address [1] 301851 0
Ethics committee country [1] 301851 0
Australia
Date submitted for ethics approval [1] 301851 0
05/11/2018
Approval date [1] 301851 0
24/01/2019
Ethics approval number [1] 301851 0
21794

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

Contacts
Principal investigator
Name 88318 0
Mrs Nicole Bijlsma
Address 88318 0
Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC. 3113
Country 88318 0
Australia
Phone 88318 0
+61 417310002
Fax 88318 0
Email 88318 0
[email protected]
Contact person for public queries
Name 88319 0
Nicole Bijlsma
Address 88319 0
Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC. 3113
Country 88319 0
Australia
Phone 88319 0
+61 41731000
Fax 88319 0
Email 88319 0
[email protected]
Contact person for scientific queries
Name 88320 0
Nicole Bijlsma
Address 88320 0
Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC.3113
Country 88320 0
Australia
Phone 88320 0
+61417310002
Fax 88320 0
Email 88320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics Approval did not include IPD sharing.


What supporting documents are/will be available?




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.