Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-28 @ 6:20 AM
Study NCT ID:
NCT04955392
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Osteopathic Treatment Protocol on Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': '1 month', 'description': 'Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability', 'timeFrame': '1 month', 'description': 'Changes in Heart Rate Variability (HRV) that will be measured and monitored before and at the end of the intervention using a portable HRV monitoring device (polar H10) that sends the signal to a computer for its collection and analysis through the Kubios HRV software'}, {'measure': 'Perceived Stress', 'timeFrame': '1 month', 'description': "Assessment of perceived stress using the Cohen's Perceived Stress Scale (PSS), which will be completed before the first intervention and one week after completing the three planned interventions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep quality', 'Heart Rate Variability', 'Stress', 'Osteopathic Manipulative Treatment', 'Manual Therapy'], 'conditions': ['Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique', 'detailedDescription': 'Intervention protocol in the intervention group:\n\nThe intervention protocol consists of 4 techniques that will be performed according to the following order:\n\n1. Inhibition of the suboccipital muscles.\n2. Parietal Lift.\n3. Sutherland Technique of Sphenobasilar Synchondrosis.\n4. Compression technique of the fourth ventricle (CV4).\n\nIntervention protocol in the control group:\n\nPlacebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index\n\nExclusion Criteria:\n\n1. Recent head injuries or fractures.\n2. Having suffered a stroke or intracranial hemorrhage.\n3. Tumors.\n4. Epilepsy.\n5. Bradycardia.\n6. Hypotension.\n7. Heart disease\n8. Neurological problems\n9. Psychiatric problems'}, 'identificationModule': {'nctId': 'NCT04955392', 'briefTitle': 'Effects of an Osteopathic Treatment Protocol on Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Ramon Mateos Fisioterapia y Osteopatía'}, 'officialTitle': 'Effects of an Osteopathic Treatment Protocol on Sleep Quality', 'orgStudyIdInfo': {'id': 'SQ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality', 'interventionNames': ['Other: Osteopathic treatment protocol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Group of patients that will receive a sham technique', 'interventionNames': ['Other: Sham technique']}], 'interventions': [{'name': 'Osteopathic treatment protocol', 'type': 'OTHER', 'description': 'The intervention protocol consists of 4 techniques that will be performed according to the following order:\n\n1. Inhibition of the suboccipital muscles.\n2. Parietal Lift.\n3. Sutherland Technique of Sphenobasilar Synchondrosis.\n4. Compression technique of the fourth ventricle (CV4).', 'armGroupLabels': ['Intervention group']}, {'name': 'Sham technique', 'type': 'OTHER', 'description': 'Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ramón Mateos Alpuente', 'role': 'CONTACT', 'email': 'info@ramonmateos.es', 'phone': '+34 620768645'}], 'facility': 'Ramón Mateos Fisioterapia y Osteopatía', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Ramón Mateos Alpuente', 'role': 'CONTACT', 'email': 'info@ramonmateos.es', 'phone': '+34 620768645'}], 'overallOfficials': [{'name': 'Ramón Mateos Alpuente', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramón Mateos Alpuente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ramón Mateos Alpuente', 'investigatorAffiliation': 'Ramon Mateos Fisioterapia y Osteopatía'}}}}