Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 7:57 AM
Study NCT ID:
NCT03797794
Status:
TERMINATED
Last Update Posted:
2024-01-19
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized, dubbel blind, placebo-controlled parallel study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Logistical problems at study site', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of oxygen saturation', 'timeFrame': '5 days', 'description': 'Difference in oxygen saturation before first vs after last session'}], 'secondaryOutcomes': [{'measure': 'Improvement of quality of life', 'timeFrame': '5 days', 'description': 'Difference in CCQ score before first vs after last session'}, {'measure': 'Improvement of exercise capacity', 'timeFrame': '5 days', 'description': 'Difference in 6-MWT outcome before first vs after last session'}, {'measure': 'Improvement of phase angle', 'timeFrame': '5 days', 'description': 'Difference in oxygen saturation before first vs after last session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': '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%.\n\nThe patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.\n\nDirectly 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients, post-bronchodilator FEV1/FVC \\<70% and FEV1 \\<50% predicted\n* oxygen saturation without suppletion \\<=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)\n* Stable medication (no foreseeable need to change therapy)\n* Able to understand the purpose and method of research after adequate information and the ability to decide on participation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Known malignant condition with limited life expectancy\n* Carrier of electrical equipment (pacemaker, ICD etc)\n* COPD exacerbation in the last 3 weeks\n* Woman who are pregnant or of childbearing age without effective contraception\n* Manifest acute infection\n* Patients with manifest decompensatio cordis\n* Rehabilitation/reactivation program within 2 months before or during the study'}, 'identificationModule': {'nctId': 'NCT03797794', 'briefTitle': 'Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'PESF and COPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PESF-treatment', 'description': 'The group undergoing the pulsating electrostatic field intervention', 'interventionNames': ['Device: Pulsating Electrostatic Field']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo-treatment', 'description': 'The group undergoing the SHAM Pulsating Electrostatic Field', 'interventionNames': ['Device: SHAM Pulsating Electrostatic Field']}], 'interventions': [{'name': 'Pulsating Electrostatic Field', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['PESF-treatment']}, {'name': 'SHAM Pulsating Electrostatic Field', 'type': 'DEVICE', 'description': "The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.", 'armGroupLabels': ['Placebo-treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8441 PW', 'city': 'Heerenveen', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Tjongerschans', 'geoPoint': {'lat': 52.95929, 'lon': 5.91854}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tjongerschans hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the department Pulmonary diseases and Tuberculosis', 'investigatorFullName': 'Huib A.M. Kerstjens', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}