An investigation of electromagnetic field exposure on sleep quality in healthy adults.

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.