Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 7:35 AM
Study NCT ID:
NCT06937632
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2025-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D000070263', 'term': 'Sleep Hygiene'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], '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': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-04-05', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Parkinson's Disease Sleep Scale (PDSS).", 'timeFrame': '3 month', 'description': "The Parkinson's Disease Sleep Scale (PDSS) was developed by (Chaudhuri et al 2002) to assess sleep quality for patients with Parkinson's disease. The scoring system of PDSS scale is:0-30 very poor sleep, 31- 60 poor, 61- 90 neutral, 91- 120 good, 121- 150 very good sleep."}], 'secondaryOutcomes': [{'measure': 'Sleep Hygiene Index (SHI)', 'timeFrame': '3 month', 'description': 'Sleep Hygiene Index was developed by (Mastin et al 2006). The Sleep Hygiene Index is a 13 item self-administered index used to assess the presence of behaviors that are thought to compromise sleep quality. The scoring system of (SHI) is: 0-12 very good sleep hygiene, 13- 26 good, 27- 40 poor, 41- 52 very poor sleep hygiene.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep', 'Sleep Hygiene', 'Sleep Quality', 'Aged', "Parkinson's disease", 'Quasi-Experimental Design'], 'conditions': ['Sleep Disorder']}, 'descriptionModule': {'briefSummary': "Sleep disorders (SDs) are one of the most frequent non-motor symptoms of Parkinson's disease (PD), usually increasing in frequency over the course of the disease and disability progression. SDs include nocturnal and diurnal manifestations such as insomnia, REM sleep behavior disorder, and excessive daytime sleepiness. The causes of SDs in PD are numerous, including the neurodegeneration process itself, which can disrupt the networks regulating the sleep-wake cycle and deplete a large number of cerebral amines possibly playing a role in the initiation and maintenance of sleep.", 'detailedDescription': 'Sleep disorders (SDs) constitute the second most frequent complaint, affecting 64% of PD patients, ranging from 41.1% in naïve patients to 78.3% in complicated patients. SDs in PD are multifactorial and include nocturnal and diurnal manifestations. Reduced sleep efficiency and an increased number of awakenings characterize sleep in PD. These disturbances are linked, on one side, to PD motor (akinesia, rigidity, and dystonia) and autonomic symptoms (nocturia) and, on the other side, to the presence of concomitant SDs such as REM sleep behavior disorder (RBD), restless legs syndrome (RLS), or breathing disorders such as obstructive sleep apnea (OSA). Diurnal manifestations include excessive daytime sleepiness (EDS) and sudden sleep attacks, which could be a consequence of nocturnal sleep impairment or dopaminergic treatment or, more interestingly, to the neurodegenerative process of PD itself dysregulating the circadian sleep-wake rhythm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '58 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.\n* Cognitively and physically able to engage in the study.\n\nExclusion Criteria:\n\n* Participants using sedative medications ."}, 'identificationModule': {'nctId': 'NCT06937632', 'briefTitle': "Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': "Effect of a Nurse-Led Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease: A Quasi-experimental Research Design", 'orgStudyIdInfo': {'id': '4/4/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventional group', 'description': 'sleep program was done three times a week for 2 weeks for the study group (6 sessions in total). It took roughly 30 minutes for each session. sessions were demonstrated during the first 3 sessions, re-demonstration of all the 3 of other sessions. Over a course of two sessions, the older adults in the intervention group were taught how to perform sleep program. The telephone number of each subject was taken to check their consistency with the proposed nursing interventions.', 'interventionNames': ['Behavioral: sleep hygiene intervention']}], 'interventions': [{'name': 'sleep hygiene intervention', 'type': 'BEHAVIORAL', 'description': 'sleep program was done three times a week for 2 weeks for the study group (6 sessions in total). It took roughly 30 minutes for each session. sessions were demonstrated during the first 3 sessions, re-demonstration of all the 3 of other sessions. Over a course of two sessions, the older adults in the intervention group were taught how to perform sleep program. The telephone number of each subject was taken to check their consistency with the proposed nursing interventions.', 'armGroupLabels': ['interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Nursing', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rasha Eweida', 'investigatorFullName': 'Rasha salah elsayed eweida', 'investigatorAffiliation': 'Alexandria University'}}}}