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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]

Nil

Universal Trial Number (UTN)

U1111-1223-2413

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sleep disturbance

Condition category

Condition code

Neurological

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]

Treatment: Devices

Comparator / control treatment

The deactivated baby monitor will be acting as a sham/placebo group.

Control group

Placebo

Outcomes

Primary outcome [1]

Severity of sleep disturbance measured using the Pittsburgh Insomnia Rating Scale 20

Timepoint [1]

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]

Cycles of activity and rest during sleep, as measured using wrist actigraphy with the Actiwatch'

Timepoint [1]

Wrist actigraphy to be worn for 29 consecutive days except during bathing

Secondary outcome [2]

Heart rate variability measured using a heart rate monitor

Timepoint [2]

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]

Polysomnography to be measured with Zmachine

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3134 - Ringwood

Recruitment postcode(s) [3]

3108 - Doncaster

Recruitment postcode(s) [4]

3153 - Bayswater

Recruitment postcode(s) [5]

3132 - Mitcham

Recruitment postcode(s) [6]

3130 - Blackburn

Recruitment postcode(s) [7]

3131 - Nunawading

Recruitment postcode(s) [8]

3113 - Warrandyte

Recruitment postcode(s) [9]

3136 - Croydon

Recruitment postcode(s) [10]

3114 - Park Orchards

Recruitment postcode(s) [11]

3135 - Heathmont

Recruitment postcode(s) [12]

3115 - Wonga Park

Recruitment postcode(s) [13]

3095 - Eltham

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

GPO Box 2476,
Melbourne VIC 3001
Australia.

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

GPO Box 2476,
Melbourne VIC 3001
Australia.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT Human Research Ethics Committee (HREC).

Ethics committee address [1]

Research Ethics Co-ordinator
Research Integrity Governance and Systems
RMIT University
GPO Box 2476
MELBOURNE  VIC  3001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/11/2018

Approval date [1]

24/01/2019

Ethics approval number [1]

21794

Summary

Brief summary

Since 2010, there has been an increase in the prevalence of sleep difficulties in adults which coincides with the use of digital devices (Adams, Appleton, Taylor, McEvoy, & Antic, 2016). This is thought to be due to the time spent surfing the internet and/or to exposure to blue light known to impact circadian entrainment, melatonin secretion, alertness, sleep regulation and the pupillary light reflex  (Bauer et al., 2018; Touitou, Touitou, & Reinberg, 2016). There is also a growing body of research investigating the impact of pulse-modulated radiofrequency electromagnetic field exposure on sleep quality, however the majority of these studies involve near head exposures to mobile phones in a sleep laboratory (Loughran, McKenzie, Jackson, Howard, & Croft, 2012; Lustenberger et al., 2013; Lustenberger et al., 2015; Schmid et al., 2012) which do not represent real world scenarios to wireless devices typically used in the home so the clinical significance to the larger population is essentially unknown. It is hypothesized that poorer subjective and objective sleep quality would be found during RF-EMF exposure compared to placebo exposure.  

Adams, R., Appleton, S., Taylor, A., McEvoy, D., & Antic, N. (2016). Report to the Sleep Health Foundation 2016 Sleep Health Survey of Australian Adults: The Adelaide Institute for Sleep Health: University of Adelaide.
Bauer, M., Glenn, T., Monteith, S., Gottlieb, J. F., Ritter, P. S., Geddes, J., & Whybrow, P. C. (2018). The potential influence of LED lighting on mental illness. World J Biol Psychiatry, 19(1), 59-73. doi:10.1080/15622975.2017.1417639
Loughran, S. P., McKenzie, R. J., Jackson, M. L., Howard, M. E., & Croft, R. J. (2012). Individual differences in the effects of mobile phone exposure on human sleep: rethinking the problem. Bioelectromagnetics, 33(1), 86-93. doi:10.1002/bem.20691
Lustenberger, C., Murbach, M., Dürr, 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 Stimulation, 6(5), 805-811. doi:https://doi.org/10.1016/j.brs.2013.01.017
Lustenberger, C., Murbach, M., Tüshaus, L., Wehrle, F., Kuster, N., Achermann, P., & Huber, R. (2015). Inter-individual and intra-individual variation of the effects of pulsed RF EMF exposure on the human sleep EEG. Bioelectromagnetics, 36(3), 169-177. doi:doi:10.1002/bem.21893
Schmid, M. R., Loughran, S. P., Regel, S. J., Murbach, M., Bratic Grunauer, A., Rusterholz, T., . . . Achermann, P. (2012). Sleep EEG alterations: effects of different pulse-modulated radio frequency electromagnetic fields. J Sleep Res, 21(1), 50-58. doi:10.1111/j.1365-2869.2011.00918.x
Touitou, Y., Touitou, D., & Reinberg, A. (2016). Disruption of adolescents' circadian clock: The vicious circle of media use, exposure to light at night, sleep loss and risk behaviors. J Physiol Paris, 110(4 Pt B), 467-479. doi:10.1016/j.jphysparis.2017.05.00

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Nicole Bijlsma

Address

Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC. 3113

Country

Australia

Phone

+61 417310002

Fax

[email protected]

Contact person for public queries

Name

Nicole Bijlsma

Address

Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC. 3113

Country

Australia

Phone

+61 41731000

Fax

[email protected]

Contact person for scientific queries

Name

Nicole Bijlsma

Address

Australian College of Environmental Studies
PO Box 188, Warrandyte. VIC.3113

Country

Australia

Phone

+61417310002

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Ethics Approval did not include IPD sharing.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email	Attachment
9915	Study protocol	WHO research protocol used	[email protected]	376315-(Uploaded-02-03-2021-14-23-14)-Study-related document.pdf
9916	Informed consent form		[email protected]	376315-(Uploaded-16-01-2021-09-53-05)-Study-related document.pdf
9917	Ethical approval		[email protected]	376315-(Uploaded-01-12-2020-16-00-41)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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