NeoplasmsNCT07791628
Electrical Grounding and Sleep Quality in Hospitalised Patients With Cancer
A study testing Earthing patch; grounding electrode in people with Neoplasms and Sleep Initiation and Maintenance Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Sleep disturbance is one of the most common and most persistent symptoms in patients admitted for cancer care, and the options available during a short hospital stay are limited. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Neoplasms, Sleep Initiation and Maintenance Disorders, Sleep Quality
- What is being tested?
- Earthing patch; grounding electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2023to 5 Jun 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients of the oncology ward aged 20 to 79 years
- Subjective complaint of insomnia, with a Pittsburgh Sleep Quality Index global score of 10 or greater at baseline
- Histologically or clinically confirmed cancer of any stage from 0 to IV
- Intact forehead skin permitting application of a grounding patch
- Scheduled hospital admission of more than three days
- Able and willing to give written informed consent
Who cannot join
- Baseline Pittsburgh Sleep Quality Index global score of 9 or less
- Known or suspected pregnancy
- History of alcohol dependence with less than two months of abstinence
- Recent use of an indoor grounding product during sleep for more than one month
- Habitually walking barefoot outdoors for more than one hour a day for more than one month
- Unable or unwilling to complete the study procedures
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
New Taipei City Municipal TuCheng Hospital
New Taipei City, TuCheng District, 236
About this study
Official title: Effects of Body Grounding Patches on Sleep Quality in Hospitalised Cancer Patients, and the Association Between Body Voltage, the Bedroom Electrical Environment and Sleep Quality: a Randomised, Sham-Controlled Trial
Sleep disturbance is one of the most common and most persistent symptoms in patients admitted for cancer care, and the options available during a short hospital stay are limited. The human body is electrically conductive, so an alternating potential - known as body voltage - is induced on the skin by mains wiring and appliances near the bed. Body voltage can be lowered by connecting the body to earth, and higher body voltage has been reported to be associated with lower vagal (parasympathetic) tone.
This randomised, sham-controlled trial tested whether nightly electrical grounding improves sleep quality in hospitalised patients with cancer who also have clinically significant insomnia. Participants wore a hydrogel patch on the forehead connected by a cord either to a true earth connection or to an externally identical cord that did not complete a conductive circuit. Grounding was applied on two consecutive nights in the oncology ward and then nightly at home until the outpatient follow-up visit. Body voltage was measured before and during grounding in both settings, so that the trial could verify objectively whether the intervention achieved its intended physical effect. Sleep quality, mood, somatic symptoms and daytime sleepiness were assessed by validated self-report questionnaires.
Read the detailed description
Design. Prospective, randomised, sham-controlled, participant-blinded, parallel two-group trial conducted in the oncology ward of New Taipei Municipal TuCheng Hospital.
Allocation. Participants were allocated to true grounding or sham grounding by a randomised block design generated with the Research Randomizer web service. The true and sham cords were externally indistinguishable, differing only in whether a conductive connection was completed internally; participants were therefore blinded to allocation. Investigators who applied the intervention and measured body voltage were necessarily aware of allocation.
Intervention. Grounding was delivered through a medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a grounding cord, with the impedance of the completed circuit limited to less than 100 ohms. In hospital the cord was connected to the earth terminal of the bedside mains outlet; at home it was connected to a metal window frame, because domestic outlets in Taiwan do not reliably provide a standard earth terminal. Grounding was applied from 21:00 to 06:00 on two consecutive nights in the ward, suspended until discharge, and then applied nightly at home for at least six hours until the outpatient follow-up visit.
Body voltage. The alternating potential at the fingertip was measured with a digital multimeter while the participant lay in bed, both before and during grounding, on each in-hospital study night and once at home.
Remote bedroom assessment. Within two days of discharge a researcher conducted a video call to record the electromagnetic environment of the bedroom using a purpose-designed questionnaire, and to teach the participant to measure body voltage and to ground safely at home.
Statistical analysis. The primary between-group treatment effect was estimated by analysis of covariance, regressing each follow-up score on allocation arm with the corresponding baseline score as covariate. Every model was repeated on rank-transformed data as a sensitivity analysis. All tests were two-sided at the 5% level.
- Conditions
- Neoplasms, Sleep Initiation and Maintenance Disorders, Sleep Quality, Cancer, Supportive Intervention, Non-invasive Intervention
- Being tested
- Earthing patch; grounding electrode, Sham (No Treatment)
- Keywords
- electrical grounding, earthing, body voltage, electromagnetic field, bedroom environment, insomnia, Pittsburgh Sleep Quality Index, oncology inpatients, sham-controlled
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earthing patch; grounding electrodeDevice
A Medical-grade hydrogel conductive patch ( 4 x 5 cm ) applied to the participants' forehead skin is connected by an electrically conductive cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the hospital ward and then nightly at home for at least six hours for 7 days before the outpatient follow-up visit.
Assigned Intervention Device: true Electrical grounding patch
Sham (No Treatment)Device
Medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a sham-grounding cord (not conductively connected ) to an earth connection point.
Assigned Intervention Device: sham-grounding cord
| Study group | Role | What they receive |
|---|---|---|
| grounding | Experimental | A hydrogel patch applied to the forehead is connected by a conductive cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the ward and then nightly at home for at least six hours until the outpatient follow-up visit. Receives: Device: Earthing patch; grounding electrode |
| sham grounding | Sham comparator | A hydrogel conductive patch applied to the participants' forehead skin is connected by an electrically 'non-conductive' cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the hospital ward and then nightly at home for at least six hours for 7 days before the outpatient follow-up visit. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PSQI scores
The PSQI is a 19-item self-report instrument assessing sleep quality over the preceding month. It yields a global score ranging from 0 to 21, obtained by summing seven component scores each rated 0 to 3. Higher scores indicate poorer sleep quality.
Measured: first: Baseline (before the first study night) second: the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge
Change in Pittsburgh Sleep Quality Index (PSQI) component scores
Seven components of the PSQI, each scored 0 to 3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher scores indicate poorer sleep.
Measured: Baseline (before the first study night) and the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge
Leeds Sleep Evaluation Questionnaire (SEQ) domain scores
Self-rated change in sleep attributable to treatment, across four domains: getting to sleep, quality of sleep, awake following sleep, and behaviour following wakening. Each domain is scored on visual analogue scales; higher scores indicate better sleep. The instrument asks the respondent to compare current sleep with the period before treatment and therefore has no pre-treatment value.
Measured: Morning after the first in-hospital study night, morning after the second in-hospital study night, and the outpatient follow-up visit 7 to 14 days after discharge
Body voltage at the fingertip
Alternating-current potential in volts, measured with a digital multimeter at the fingertip while the participant lies in bed, recorded immediately before and during grounding. Lower values indicate less induced electrical potential on the body.
Measured: Once at first enrollment (on the day before two in-hospital study nights), and once in the participant's own bedroom within 2 days of hospital discharge
Secondary outcomes (3)
Change in Hospital Anxiety and Depression Scale (HADS) score
Chinese version of the HADS. Anxiety and depression subscales each range from 0 to 21 and the total score from 0 to 42. Higher scores indicate greater distress.
Measured: Baseline and the outpatient follow-up visit 7 to 14 days after discharge
Change in Depression and Somatic Symptoms Scale (DSSS) score
Chinese version of the DSSS, assessing depressive and somatic symptoms. Higher scores indicate more severe symptoms.
Measured: Baseline and the outpatient follow-up visit 7 to 14 days after discharge
Change in Karolinska Sleepiness Scale (KSS) daily total
Subjective sleepiness rated on a 9-point scale in the morning, afternoon and evening and summed to a daily total ranging from 3 to 27. Higher scores indicate greater sleepiness.
Measured: Baseline, the mornings following each of the two in-hospital study nights, and the outpatient follow-up visit 7 to 14 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start25 Oct 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Hsien Tu, MD, Principal investigator, New Taipei City Municipal TuCheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791628
- Sponsor's protocol ID
- 202201526B0
- Other IDs
- CORPVVN005, 202201526B0C601
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Grounding Patches on Sleep Quality in Hospitalised Cancer Patients, and the Association Between Body Voltage, the Bedroom Electrical Environment and Sleep Quality: a Randomised, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07791628
- Acronym / sponsor ID
- 202201526B0
- Conditions
- Neoplasms, Sleep Initiation and Maintenance Disorders, Sleep Quality, Cancer, Supportive Intervention, Non-invasive Intervention
- Keywords
- electrical grounding, earthing, body voltage, electromagnetic field, bedroom environment, insomnia, Pittsburgh Sleep Quality Index, oncology inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 28 Aug 2026 (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.
Sleep disturbance is one of the most common and most persistent symptoms in patients admitted for cancer care, and the options available during a short hospital stay are limited. The human body is electrically conductive, so an alternating potential - known as body voltage - is induced on the skin by mains wiring and appliances near the bed. Body voltage can be lowered by connecting the body to earth, and higher body voltage has been reported to be associated with lower vagal (parasympathetic) tone.
This randomised, sham-controlled trial tested whether nightly electrical grounding improves sleep quality in hospitalised patients with cancer who also have clinically significant insomnia. Participants wore a hydrogel patch on the forehead connected by a cord either to a true earth connection or to an externally identical cord that did not complete a conductive circuit. Grounding was applied on two consecutive nights in the oncology ward and then nightly at home until the outpatient follow-up visit. Body voltage was measured before and during grounding in both settings, so that the trial could verify objectively whether the intervention achieved its intended physical effect. Sleep quality, mood, somatic symptoms and daytime sleepiness were assessed by validated self-report questionnaires.
Detailed description
Design. Prospective, randomised, sham-controlled, participant-blinded, parallel two-group trial conducted in the oncology ward of New Taipei Municipal TuCheng Hospital.
Allocation. Participants were allocated to true grounding or sham grounding by a randomised block design generated with the Research Randomizer web service. The true and sham cords were externally indistinguishable, differing only in whether a conductive connection was completed internally; participants were therefore blinded to allocation. Investigators who applied the intervention and measured body voltage were necessarily aware of allocation.
Intervention. Grounding was delivered through a medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a grounding cord, with the impedance of the completed circuit limited to less than 100 ohms. In hospital the cord was connected to the earth terminal of the bedside mains outlet; at home it was connected to a metal window frame, because domestic outlets in Taiwan do not reliably provide a standard earth terminal. Grounding was applied from 21:00 to 06:00 on two consecutive nights in the ward, suspended until discharge, and then applied nightly at home for at least six hours until the outpatient follow-up visit.
Body voltage. The alternating potential at the fingertip was measured with a digital multimeter while the participant lay in bed, both before and during grounding, on each in-hospital study night and once at home.
Remote bedroom assessment. Within two days of discharge a researcher conducted a video call to record the electromagnetic environment of the bedroom using a purpose-designed questionnaire, and to teach the participant to measure body voltage and to ground safely at home.
Statistical analysis. The primary between-group treatment effect was estimated by analysis of covariance, regressing each follow-up score on allocation arm with the corresponding baseline score as covariate. Every model was repeated on rank-transformed data as a sensitivity analysis. All tests were two-sided at the 5% level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grounding | Experimental | Device: Earthing patch; grounding electrodeA hydrogel patch applied to the forehead is connected by a conductive cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the ward and then nightly at home for at least six hours until the outpatient follow-up visit. |
| sham grounding | Sham comparator | Device: Sham (No Treatment)A hydrogel conductive patch applied to the participants' forehead skin is connected by an electrically 'non-conductive' cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the hospital ward and then nightly at home for at least six hours for 7 days before the outpatient follow-up visit. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatients of the oncology ward aged 20 to 79 years
- Subjective complaint of insomnia, with a Pittsburgh Sleep Quality Index global score of 10 or greater at baseline
- Histologically or clinically confirmed cancer of any stage from 0 to IV
- Intact forehead skin permitting application of a grounding patch
- Scheduled hospital admission of more than three days
Key exclusion criteria (6 listed)
- Baseline Pittsburgh Sleep Quality Index global score of 9 or less
- Known or suspected pregnancy
- History of alcohol dependence with less than two months of abstinence
- Recent use of an indoor grounding product during sleep for more than one month
- Habitually walking barefoot outdoors for more than one hour a day for more than one month
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 |
|---|---|---|
| Earthing patch; grounding electrodeA Medical-grade hydrogel conductive patch ( 4 x 5 cm ) applied to the participants' forehead skin is connected by an electrically conductive cord to a true earth connection (the earth terminal of the bedside mains outlet in hospital, or a metal window frame at home). Applied from 21:00 to 06:00 on two consecutive nights in the hospital ward and then nightly at home for at least six hours for 7 days before the outpatient follow-up visit. Assigned Intervention Device: true Electrical grounding patch | Device | grounding |
| Sham (No Treatment)Medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a sham-grounding cord (not conductively connected ) to an earth connection point. Assigned Intervention Device: sham-grounding cord | Device | sham grounding |
Primary outcome
Change in PSQI scores
Time frame: first: Baseline (before the first study night) second: the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge
The PSQI is a 19-item self-report instrument assessing sleep quality over the preceding month. It yields a global score ranging from 0 to 21, obtained by summing seven component scores each rated 0 to 3. Higher scores indicate poorer sleep quality.
Change in Pittsburgh Sleep Quality Index (PSQI) component scores
Time frame: Baseline (before the first study night) and the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge
Seven components of the PSQI, each scored 0 to 3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher scores indicate poorer sleep.
Leeds Sleep Evaluation Questionnaire (SEQ) domain scores
Time frame: Morning after the first in-hospital study night, morning after the second in-hospital study night, and the outpatient follow-up visit 7 to 14 days after discharge
Self-rated change in sleep attributable to treatment, across four domains: getting to sleep, quality of sleep, awake following sleep, and behaviour following wakening. Each domain is scored on visual analogue scales; higher scores indicate better sleep. The instrument asks the respondent to compare current sleep with the period before treatment and therefore has no pre-treatment value.
Body voltage at the fingertip
Time frame: Once at first enrollment (on the day before two in-hospital study nights), and once in the participant's own bedroom within 2 days of hospital discharge
Alternating-current potential in volts, measured with a digital multimeter at the fingertip while the participant lies in bed, recorded immediately before and during grounding. Lower values indicate less induced electrical potential on the body.
3 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline and the outpatient follow-up visit 7 to 14 days after discharge
Change in Depression and Somatic Symptoms Scale (DSSS) score
Time frame: Baseline and the outpatient follow-up visit 7 to 14 days after discharge
Change in Karolinska Sleepiness Scale (KSS) daily total
Time frame: Baseline, the mornings following each of the two in-hospital study nights, and the outpatient follow-up visit 7 to 14 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Chun-Hsien Tu, MD principal investigator
New Taipei City Municipal TuCheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earthing patch; grounding electrode in people with Neoplasms and Sleep Initiation and Maintenance Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Aug 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in PSQI scores (time frame: first: Baseline (before the first study night) second: the outpatient follow-up visit, scheduled 7 to 14 days after hospital discharge). The study lists 4 primary outcomes in all. 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 28 Aug 2026.