COPDNCT03797794
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
A study testing Pulsating Electrostatic Field in people with COPD, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulsating Electrostatic Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 31 Dec 2023
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients, post-bronchodilator FEV1/FVC <70% and FEV1 <50% predicted
- oxygen saturation without suppletion <=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
- Stable medication (no foreseeable need to change therapy)
- Able to understand the purpose and method of research after adequate information and the ability to decide on participation
- Signed informed consent
Who cannot join
- Known malignant condition with limited life expectancy
- Carrier of electrical equipment (pacemaker, ICD etc)
- COPD exacerbation in the last 3 weeks
- Woman who are pregnant or of childbearing age without effective contraception
- Manifest acute infection
- Patients with manifest decompensatio cordis
- Rehabilitation/reactivation program within 2 months before or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.
The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.
The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.
Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.
- Conditions
- COPD
- Being tested
- Pulsating Electrostatic Field, SHAM Pulsating Electrostatic Field
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsating Electrostatic FieldDevice
A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes.
SHAM Pulsating Electrostatic FieldDevice
The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.
| Study group | Role | What they receive |
|---|---|---|
| PESF-treatment | Experimental | The group undergoing the pulsating electrostatic field intervention Receives: Device: Pulsating Electrostatic Field |
| Placebo-treatment | Sham comparator | The group undergoing the SHAM Pulsating Electrostatic Field Receives: Device: SHAM Pulsating Electrostatic Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of oxygen saturation
Difference in oxygen saturation before first vs after last session
Measured: 5 days
Secondary outcomes (3)
Improvement of quality of life
Difference in CCQ score before first vs after last session
Measured: 5 days
Improvement of exercise capacity
Difference in 6-MWT outcome before first vs after last session
Measured: 5 days
Improvement of phase angle
Difference in oxygen saturation before first vs after last session
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Logistical problems at study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Model description
- prospective, randomized, dubbel blind, placebo-controlled parallel study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Tjongerschans hospital
- Responsible party
- Principal investigator, Huib A.M. Kerstjens, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797794
- Sponsor's protocol ID
- PESF and COPD
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT03797794
- Acronym / sponsor ID
- PESF and COPD
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical problems at study site
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Tjongerschans hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jan 2019 (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.
The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.
The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.
Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized, dubbel blind, placebo-controlled parallel study
| Arm | Type | Receives |
|---|---|---|
| PESF-treatment | Experimental | Device: Pulsating Electrostatic FieldThe group undergoing the pulsating electrostatic field intervention |
| Placebo-treatment | Sham comparator | Device: SHAM Pulsating Electrostatic FieldThe group undergoing the SHAM Pulsating Electrostatic Field |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patients, post-bronchodilator FEV1/FVC <70% and FEV1 <50% predicted
- oxygen saturation without suppletion <=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
- Stable medication (no foreseeable need to change therapy)
- Able to understand the purpose and method of research after adequate information and the ability to decide on participation
- Signed informed consent
Key exclusion criteria (7 listed)
- Known malignant condition with limited life expectancy
- Carrier of electrical equipment (pacemaker, ICD etc)
- COPD exacerbation in the last 3 weeks
- Woman who are pregnant or of childbearing age without effective contraception
- Manifest acute infection
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 |
|---|---|---|
| Pulsating Electrostatic FieldA pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes. | Device | PESF-treatment |
| SHAM Pulsating Electrostatic FieldThe same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo. | Device | Placebo-treatment |
Primary outcome
Improvement of oxygen saturation
Time frame: 5 days
Difference in oxygen saturation before first vs after last session
3 secondary outcomes
Improvement of quality of life
Time frame: 5 days
Improvement of exercise capacity
Time frame: 5 days
Improvement of phase angle
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Logistical problems at study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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 Pulsating Electrostatic Field in people with COPD, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 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: stopped early, as of the sponsor's last update on 19 Jan 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 Netherlands. 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 was stopped early (reason given: Logistical problems at study site). 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?
Improvement of oxygen saturation (time frame: 5 days). 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 19 Jan 2024.