Electrical Grounding and Sleep Quality in Hospitalised Patients With Cancer

NCT07791628 | Completed

• 3 other identifiers: 202201526B0CORPVVN005202201526B0C601
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders; Sleep Quality; Cancer; Supportive Intervention; Non-invasive Intervention; Non-pharmacological Intervention; Environmental Factor

Keywords

electrical grounding; earthing; body voltage; electromagnetic field; bedroom environment; insomnia; Pittsburgh Sleep Quality Index; oncology inpatients; sham-controlled

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline and the outpatient follow-up visit 7 to 14 days after discharge

• Change in Depression and Somatic Symptoms Scale (DSSS) score

  Baseline and the outpatient follow-up visit 7 to 14 days after discharge

• Change in Karolinska Sleepiness Scale (KSS) daily total

  Baseline, the mornings following each of the two in-hospital study nights, and the outpatient follow-up visit 7 to 14 days after discharge

Other Outcomes (1)

• Bedroom Electromagnetic Environment Questionnaire (BrEQ)

  Once, during the remote video assessment within 2 days of hospital discharge

Study Arms (2)

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.

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.

Device: Sham (No Treatment)

Interventions

Earthing patch; grounding electrode DEVICE

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

grounding

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

sham grounding

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

New Taipei City Municipal TuCheng Hospital

New Taipei City, TuCheng District, 236, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chun-Hsien Tu, MD

  New Taipei City Municipal TuCheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start: October 25, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)