SleepNCT04583397
Effects of WiFi Exposure on Sleep in Women
A study testing radio frequency electromagnetic fields in people with Sleep, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Effects of Wifi exposure on sleep and sleep-related memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design in young healthy women. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- radio frequency electromagnetic fields
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only right-handed
- non-smokers
- Pittsburgh Sleep Quality Index (PSQI) score < 5
- no extreme morning/evening preference [Morningness-Eveningness Questionnaire (MEQ) score ≥ 31 or ≤ 69
- no indication of depression or somatic symptoms as assessed by a medical examination and validated questionnaires [Patient Health Questionnaires (PHQ-9 and PHQ-15) scores ≤ 5 and ≤ 10, respectively
Who cannot join
- history of a psychiatric disorder,
- history of a neurological and/or sleep disorder
- excessive daytime sleepiness [Epworth Sleepiness Scale (ESS) score > 9;
- non-regular sleep-wake schedule as assessed by a sleep diary
- a regular intake of medication that affects the central nervous system, excessive caffeine and/or alcohol consumption, regular and occasional drug use,
- metal implants
- periodic leg movement arousal index > 10/h in the Adaptation night
- apnoea-hypopnoea-index > 5/h in the Adaptation night.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of WiFi Exposure on Sleep and Sleep Related Memory Consolidation in Young Healthy Women
Effects of Wifi exposure on sleep and sleep-related memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design in young healthy women.
Read the detailed description
Introduction: Since several years Wireless Local Networks (WLAN, WiFi) are widely spread and operated in households. Many people feel that the presence of radiofrequency technologies impairs their health. Sleep problems are among the most often complained complaints. The present study aims to contribute to answer the question, whether biological effects of a WiFi exposure can be assessed by objective measures. The results of this study will expand the database on possible acute effects of WiFi exposure and thus qualitatively contribute to the discussion whether sleep is affected by exposure from radiofrequency electromagnetic fields.
Methods: A double-blind, sham-controlled experiment in the sleep laboratory with exposure conditions delivered in a balanced randomized cross-over design. Subjective sleep quality of volunteers is assessed by questionnaires. Macro- and microstructure of sleep are measured by polysomnography. Furthermore, a possible impact on sleep related memory consolidation is tested. To do so declarative, procedural and emotional memory tasks are used. Exposure is delivered by a specially developed system, which simulates field strengths and signals occurring in a subject sleeping in the close proximity of a WiFi-access point. This exposure system is necessary to allow for a double-blind implementation and monitoring as well as for the realization of defined exposure parameters.
The study aims to analyse possible sex differences in WiFi exposure effects on sleep and sleep related memory consolidation.
- Conditions
- Sleep
- Being tested
- radio frequency electromagnetic fields
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radio frequency electromagnetic fieldsOther
Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: WiFi - Sham | Experimental | first intervention WiFi, second intervention sham Receives: Other: radio frequency electromagnetic fields |
| Experimental: Sham - WiFi | Experimental | first Intervention sham, second Intervention WiFi Receives: Other: radio frequency electromagnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency index
(total Sleep time in % of time in bed)
Measured: 8 hours
Secondary outcomes (2)
declarative memory
number of remembered word pairs in the Word Association Task
Measured: 8 hours
Sleep EEG power
EEG power in the spindle frequency range
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Feb 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Corona
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Seibersdorf Labor GmbH
- Responsible party
- Principal investigator, Heidi Danker-Hopfe, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583397
- Sponsor's protocol ID
- EA4/074/19
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of WiFi Exposure on Sleep and Sleep Related Memory Consolidation in Young Healthy Women
- ClinicalTrials.gov ID
- NCT04583397
- Acronym / sponsor ID
- EA4/074/19
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Corona
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Seibersdorf Labor GmbH
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Wifi exposure on sleep and sleep-related memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design in young healthy women.
Detailed description
Introduction: Since several years Wireless Local Networks (WLAN, WiFi) are widely spread and operated in households. Many people feel that the presence of radiofrequency technologies impairs their health. Sleep problems are among the most often complained complaints. The present study aims to contribute to answer the question, whether biological effects of a WiFi exposure can be assessed by objective measures. The results of this study will expand the database on possible acute effects of WiFi exposure and thus qualitatively contribute to the discussion whether sleep is affected by exposure from radiofrequency electromagnetic fields.
Methods: A double-blind, sham-controlled experiment in the sleep laboratory with exposure conditions delivered in a balanced randomized cross-over design. Subjective sleep quality of volunteers is assessed by questionnaires. Macro- and microstructure of sleep are measured by polysomnography. Furthermore, a possible impact on sleep related memory consolidation is tested. To do so declarative, procedural and emotional memory tasks are used. Exposure is delivered by a specially developed system, which simulates field strengths and signals occurring in a subject sleeping in the close proximity of a WiFi-access point. This exposure system is necessary to allow for a double-blind implementation and monitoring as well as for the realization of defined exposure parameters.
The study aims to analyse possible sex differences in WiFi exposure effects on sleep and sleep related memory consolidation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: WiFi - Sham | Experimental | Other: radio frequency electromagnetic fieldsfirst intervention WiFi, second intervention sham |
| Experimental: Sham - WiFi | Experimental | Other: radio frequency electromagnetic fieldsfirst Intervention sham, second Intervention WiFi |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Only right-handed
- non-smokers
- Pittsburgh Sleep Quality Index (PSQI) score < 5
- no extreme morning/evening preference [Morningness-Eveningness Questionnaire (MEQ) score ≥ 31 or ≤ 69
- no indication of depression or somatic symptoms as assessed by a medical examination and validated questionnaires [Patient Health Questionnaires (PHQ-9 and PHQ-15) scores ≤ 5 and ≤ 10, respectively
Key exclusion criteria (8 listed)
- history of a psychiatric disorder,
- history of a neurological and/or sleep disorder
- excessive daytime sleepiness [Epworth Sleepiness Scale (ESS) score > 9;
- non-regular sleep-wake schedule as assessed by a sleep diary
- a regular intake of medication that affects the central nervous system, excessive caffeine and/or alcohol consumption, regular and occasional drug use,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radio frequency electromagnetic fieldsExposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure) | Other | Experimental: Sham - WiFi, Experimental: WiFi - Sham |
Primary outcome
Sleep Efficiency index
Time frame: 8 hours
(total Sleep time in % of time in bed)
2 secondary outcomes
declarative memory
Time frame: 8 hours
Sleep EEG power
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radio frequency electromagnetic fields in people with Sleep, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency index (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.